chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. Between 18-AUG-2015 and 21-AUG-2015, an unspecified number of patients were vaccinated with unspecified doses in series of GARDASIL lot # K010215, expiry date 05-MAY-2017 (dose, site and route of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a female patient of unknown age. The patient's concurrent condition, medical history or concomitant medications were not reported. On unspecified date in 2010 the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, lot #, expiration date and route of administration not reported). On unspecified date in 2011 the patient was inadvertently vaccinated with the second dose of PNEUMOVAX 23 (dose, lot #, expiration date and route of administration not reported). No adverse effects were reported. Additional information is not expected as the reporter declined any further contact.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple patients of unspecified age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions or allergies was reported. On an unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot#K007826, expiration date: 03-FEB-2016; dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 28.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 28 year old patient of unknown gender with a medical history of asthma. There was no information about concomitant medications, drug reactions or allergies provided. On 31-AUG-2015, the patient was vaccinated with an expired dose of PNEUMOVAX (lot# K010016, expiration date 05-AUG-2015, dose, site and route of administration were not reported). The patient had not experienced any adverse effects. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 27-AUG-2015, the patient was vaccinated with an expired dose of GARDASIL, lot # K001502, expiration date 06-AUG-2015, (dose, route of administration and injection site were not reported). The nurse stated that the dose received was the patient's first dose in her Human Papilloma Virus (HPV) vaccination series. It was also reported that the patient had not experienced any adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received form a certified medical assistant refers to five patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. In July 2015, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # K021935, expiration date: 10-NOV-2016), dose and route were not reported. No adverse effects reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Pain, itching, swelling. Rx: observation.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Body temperature increased, Dizziness, Injection site pain
Clinical narrative: Temp - 99.7, pulse 105-120 dizzy, pain to (L) deltoid, arm treatment: rest, TYLENOL.
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was vaccinated intramuscularly with a dose of GARDASIL injection (dose, lot# and expiry date were not reported). There were no concomitant therapies reported. On an unknown date, the patient developed an unspecified rash, described as hives, in an unspecified location. The outcome of the event was not reported. The relatedness between GARDASIL and the event was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions reported. The reporter stated that on unspecified dates, the patients were vaccinated with unspecified number of doses of improperly stored (Oka/Merck) VARIVAX injection (lot # K008824, expiration date 19-JUN-2016, lot# L011083 expiration date 01-APR-2017 and lot# K002927 with expiration date 26-FEB-2016, strength, dose and route were not provided). There was no concomitant medication. No adverse experiences were reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Reddened area on arm with some edema above elbow.
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No medical history, concurrent conditions or concomitant therapies were reported. On unknown dates in 2010, the patient was vaccinated with two doses of GARDASIL (lot #, expiration date, dose, route of administration and anatomical  location were not reported). On an unknown date, the patient received the third dose of GARDASIL 9 (lot #, expiration date, dose, route of administration and anatomical location were not reported) because GARDASIL was not available. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple patients of unspecified age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions or allergies was reported. On an unspecified dates, the patients were vaccinated with improperly stored GARDASIL (lot # K006191, expiration date: 02-FEB-2017; dose, route of administration and anatomical location were not reported). 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: This initial spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions reported. The reporter stated that on unspecified dates, the patients were vaccinated with unspecified number of doses of improperly stored PROQUAD (Merck) injection (lot # K007797 with expiration date 29-NOV-2015, strength, dose and route were not provided). There was no concomitant medication. No adverse experiences were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician 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 31-AUG-2015, the patient was vaccinated with an expired dose of RECOMBIVAX HB, lot # J014232, expiration date 29-AUG-2015, (dose, route of administration and injection site were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple refers of unspecified age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies was reported. On an unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # K026242, expiration date: 28-JAN-2017; dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: TC from mom on 8/31/15 8AM, states child experienced 102 degree fever w/n 48 hrs of injection. Site became red, swollen and hot to touch and is still like that 5 days post injection. Giving TYLENOL, applying compresses, giving BENADRYL.
Age: 73.0
Sex: F
Vaccine: HIBV
Symptoms: Erythema, Pruritus
Clinical narrative: Arm became red and itchy, took BENADRYL went away after 2 days.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site urticaria
Clinical narrative: Edema, urticaria at site.
Age: 1.09
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Rash morbilliform
Clinical narrative: Morbiliform rash and fever and febrile seizure on 8/29/15 seen at ER.
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician via a field representative concerning a female patient of unknown age. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route not reported) for preventing HPV. The patient received the GARDASIL 9 as the first dose of the scheduled 3 doses. On an unspecified date, the patient experienced hives. The outcome of hives was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. There was no pertinent medical history or drug allergies/drug reactions reported. The reported stated that on 25-AUG-2015, the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX injection (lot # J006694 with expiration date 30-MAY-2015; strength, dose and route were not provided). There was no concomitant medication reported. No product quality complaint was involved and no adverse experiences were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a certified diabetes educator of unknown age who was reporting on herself, via a company representative. There were no concomitant therapies, concurrent conditions or medical history provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date not reported). On an unknown date (reported as "5 years later almost to the day"), the patient developed shingles. The outcome of shingles was not reported. The reporter did not assess the relatedness between the adverse event and the ZOSTAVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report was received from a pharmacist via a market research program on 01-SEP-2015, and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patients were vaccinated with zoster vaccine live (manufacturer unknown) (lot number, expiration dates, dates of vaccination, dose and route of administration were not reported). There was no concomitant medication reported. The reporter stated that on an unspecified dates, the patients had coming up to him, and reported that they still had shingles (herpes zoster) after receiving the vaccine. The reporter stated that the patients had a vaccination failure. At the reporting time, the outcome of herpes zoster and vaccination failure was unknown. Additionally, the reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (manufacturer unknown). Additional information is not expected because the reporter did not consent for new follow up attempts.
Sex: M
Vaccine: VARZOS
Symptoms: Arthropod bite, Rash
Clinical narrative: This spontaneous report was received from a male consumer of an unknown age reporting on himself. The patient's concurrent condition and medical history were not provided. On 25-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous in his arm (unspecified arm) (lot No. and expiration date were not provided). Concomitant therapy was not provided. The patient reported that after he received the dose of ZOSTAVAX on 25-AUG-2015, he noticed an insect bite on his leg (unspecified leg). The insect bite was treated with an unspecified antibiotic. Since using this unspecified antibiotic the patient's leg had developed a rash approximately at the end of August 2015 (1509USA001246). At the time of the report, the insect bite was not recovered. It was unspecified if lab diagnostic studies were performed. The patient did seek medical attention at an office visit. The consumer did not provide the relation between the insect bite and ZOSTAVAX. Additional information is not expected as no reported details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a healthcare student. The reporter stated that an unspecified physician had an unspecified patient of unknown age and gender. No concurrent or historical medication was reported. In approximately August 2014 (also reported as "1 years ago") the patient was vaccinated with ZOSTAVAX (unspecified lot number and expiration date), dose, route, and anatomical location were unknown. No concomitant medication was reported. On an unknown date (also reported as "recently") the patient experienced shingles. The Varicella-Zoster Virus (VZV) packet was declined. At the time of the report the outcome of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning to multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history or concurrent conditions were not provided. On an unknown dates the patients were vaccinated with an unspecified doses of improperly stored of GARDASIL, lot # k009202, expiration date: 17-DEC-2016 (routes, anatomical locations and doses were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (dose, frequency, route of administration, lot # and expiration date were not provided). No concomitant medication was reported. The reporter stated that the patient had recurring shingles, since an unknown date. At the time of reporting, the outcome of recurring shingles was unknown. The reporter did not assess the relationship between ZOSTAVAX and the recurring shingles. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning to multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history or concurrent conditions were not provided. On an unknown dates the patients were vaccinated with an unspecified doses of improperly stored MMR II, lot # K002816, expiration date: 26-FEB-2015 (routes, anatomical locations and doses were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD (Merck) (L016394; expiry: 08-NOV-2016) (dose, route and frequency unspecified). Other suspect therapies included VARIVAX (Merck) (dose, route, frequency and lot # unspecified). Concomitant medications and medical history were not reported. Nurse reported that on an unknown date VARIVAX (Merck) and PROQUAD (Merck) were inadvertently administered to a patient during the same office visit (overdose). No adverse effects reported. No additional information to report. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple patients of unspecified age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions or allergies was reported. On an unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K010216, expiration date: 17-SEP-2016, and lot# K02144, expiration date: 17-SEP-2016; dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received 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 healthcare worker refers to a patient of unknown age. On an unknown date, the patient was vaccinated with an improperly stored (Oka/Merck) VARIVAX lot # K006138, expiry date 29-APR-2016 and no adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 09-FEB-2015, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly, lot # K008213, expiration date 17-DEC-2016. On 08-MAY-2015, the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscularly, lot # K014191, expiration date 10-MAY-2017. On 24-JUL-2015, the patient was vaccinated with the third dose of GARDASIL 0.5 ml, intramuscularly, lot # K023432, expiration date 18-JUN-2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple patients of unspecified age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions or allergies was reported. On an unspecified dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot # K008874, expiration date: 23-FEB-2017 and K026533, expiration date: 07-AUG-2017; dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning an 18 months old patient of gender unknown. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date at 15 months of age, the patient was vaccinated with the first dose of MMR II (route and lot number not provided). On an unspecified date at 18 months of age the patient was administered the second dose of MMR II (route and lot number not provided). No adverse effect was reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to her 13 year old daughter. The patient's pertinent medical history and drug allergies were none. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency and lot# were unknown) intramuscular. Concomitant medications were none. On an unknown date, the patient experienced shooting pain down her neck minutes after receiving the vaccine. The reporter notified the physician and sought medical attention. No treatment was provided for the event. The outcome of the events was reported as recovered/resolved (reported as went away the following day). The relatedness of the events with GARDASIL was not provided. 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 referring to a patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of VARIVAX (dose and route of administration were not reported; lot # K018961 with expiration date: 15-OCT-2016), which underwent defrost cycling. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of PROQUAD (Merck) (dose and route of administration were not reported; lot # K025764 with expiration date: 08-JUN-2016 and lot# L007230 with expiration date: 03-SEP-2016), which underwent defrost cycling. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pharyngitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with an allergy to possibly penicillin (manufacturer unknown). The patient's medical history included unspecified lung surgery in October 2014. On 17-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route of administration, lot# and expiration date were not reported). The patient's concomitant therapy was reported as unspecified topical medications. On 20-AUG-2015, the patient developed pharyngitis and unspecified blisters (four or so on her left hand, two on her right hand, and a few on her stomach) after receiving ZOSTAVAX. No treatment was given for the adverse events and no laboratory tests were performed. The patient went into a pharmacy on 25-AUG-2015 and informed the pharmacist of the events. The outcome of pharyngitis and blister was reported as not recovered. Causality assessment between the adverse events and the therapy with ZOSTAVAX was not provided. This is one of two reports concerning the same patient. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patients were vaccinated with 9 doses of improperly stored doses of PROQUAD (Merck) (lot# and expiration date reported as L016393, 08-NOV-2016) (dose, route of administration and frequency were unspecified). No adverse effects reported. Concomitant medications were not provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning to an unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not informed. On an unknown date, the patients may have been vaccinated with unspecified doses of ZOSTAVAX (Dose, route, frequency and lot No. were not provided), which were transported on dry ice. No concomitant medication was reported. No adverse effects were reported. No product quality complaint was informed. Additional information is not expected as the reporter did not provide consent for follow up.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Food intolerance, Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Mother of pt states morning after vaccinations (Var, hep A) patient woke up with redness, swelling and "hot" around Varicella vaccine site. Gave him BENADRYL per her sister's advice and took to pediatrician. Per mom, pain and swelling continued to worsen for a day then started to improve. Gave BENADRYL and TYLENOL Tues-Sunday and didn't need any meds and completely resolved by Mon 8/31. 8-24-2015 151 lbs. Administered hep A #1 and varicella #1. Reminder set for 3 months for varicella 2; 6 months for hep A 2. Wrote out conditional for school-3mo for varicella #2 and mom took original (copy scanned with registration/superbill). 8-28-2015 Fax of office visit from Pediatric office discovered 8/27 on downstairs fax missing cover page. Patient seen 8/25 for reaction to varicella vaccine. Called mother, left message on answering machine to return call r/t reaction. 9-1-2015 Called pt's mother again, this time able to reach her. She stated that on 8/25/2015, patient woke up with red swollen arm that was "hot" to touch and painful. She states his pain got worse during the day, she gave him BENADRYL on her sister's advice, and took him to pediatric clinic. HPC provider assessed as afebrile local reaction to varicella vaccine and advised mother to treat symptoms with TYLENOL and return to clinic if worsened. No measurements documented in notes. Mother states that she continued to give him BENADRYL once daily along with TYLENOL until Sunday 8/30. She stated that the arm pain and redness and swelling were completely resolved by Monday a.m. But she states that now he can't eat chicken or eggs because he complains of his throat. I explained "throat swelling" would be considered an emergency for her to contact physician immediately. I advised that no chicken or eggs in the varicella vaccine. I verified that prior to the vaccinations on 8/24 he had no known allergies to food or medicines; she stated that was correct, but that her sister had a bad reaction to chicken pox and flu shot and can't receive them any longer. I advised her to discuss allergy testing with patient's pediatrician to identify actual allergen (possibly other ingredient such as neomycin or gelatin), and a temporary medical exemption to the 2nd dose of varicella for school until allergy/ies can be ascertained. Mother states she understands and will do that. When asked if there was any swelling or visible reaction at the hepatitis A site, mom stated there was none. VAERS submitted.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Pharyngeal disorder, Skin warm, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Mother of pt states morning after vaccinations (Var, hep A) patient woke up with redness, swelling and "hot" around Varicella vaccine site. Gave him BENADRYL per her sister's advice and took to pediatrician. Per mom, pain and swelling continued to worsen for a day then started to improve. Gave BENADRYL and TYLENOL Tues-Sunday and didn't need any meds and completely resolved by Mon 8/31. 8-24-2015 151 lbs. Administered hep A #1 and varicella #1. Reminder set for 3 months for varicella 2; 6 months for hep A 2. Wrote out conditional for school-3mo for varicella #2 and mom took original (copy scanned with registration/superbill). 8-28-2015 Fax of office visit from Pediatric office discovered 8/27 on downstairs fax missing cover page. Patient seen 8/25 for reaction to varicella vaccine. Called mother, left message on answering machine to return call r/t reaction. 9-1-2015 Called pt's mother again, this time able to reach her. She stated that on 8/25/2015, patient woke up with red swollen arm that was "hot" to touch and painful. She states his pain got worse during the day, she gave him BENADRYL on her sister's advice, and took him to pediatric clinic. HPC provider assessed as afebrile local reaction to varicella vaccine and advised mother to treat symptoms with TYLENOL and return to clinic if worsened. No measurements documented in notes. Mother states that she continued to give him BENADRYL once daily along with TYLENOL until Sunday 8/30. She stated that the arm pain and redness and swelling were completely resolved by Monday a.m. But she states that now he can't eat chicken or eggs because he complains of his throat. I explained "throat swelling" would be considered an emergency for her to contact physician immediately. I advised that no chicken or eggs in the varicella vaccine. I verified that prior to the vaccinations on 8/24 he had no known allergies to food or medicines; she stated that was correct, but that her sister had a bad reaction to chicken pox and flu shot and can't receive them any longer. I advised her to discuss allergy testing with patient's pediatrician to identify actual allergen (possibly other ingredient such as neomycin or gelatin), and a temporary medical exemption to the 2nd dose of varicella for school until allergy/ies can be ascertained. Mother states she understands and will do that. When asked if there was any swelling or visible reaction at the hepatitis A site, mom stated there was none. VAERS submitted.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 47 year old female patient. The reporter read a frequently asked questions (FAQ) from a facility in which the patient on an unknown date, was inadvertently vaccinated with a dose of ZOSTAVAX (unknown strength, dose) instead of VARIVAX. Concomitant medications were not reported. It was unknown if any adverse effects occurred. There was no product quality complaint involved. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 3 year old female patient. The patient's concurrent conditions and medical history were not provided. On 26-AUG-2015, the patient was inadvertently vaccinated with an unspecified dose of PNEUMOVAX 23, injection, 0.5 ml (route of administration, anatomical location, expiration date and lot number were not reported) instead of PREVNAR. No adverse effect was reported. There were not concomitant medications reported. The patient was at the physician office for medical attention and she did not received any treatment. There was not product quality issue involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Overdose
Clinical narrative: This spontaneous report was received from the Local Health Authority (Agency # STN103606) in a news article concerning 250 children of unspecified genders whom on an unspecified dates (reported as the course of the last week), received the adult dosage of the Hepatitis A vaccine (Lot #, doses and routes not reported). The children were being monitored for possible side effects after the facility gave them adult dosages as the prescribed amount for adults as nearly double that for children. The officials stated that none of the affected children had so far experienced any adverse reactions and close monitoring would continue over the next five days, and the children's caregivers at the facility were counseled on what health issues could arise. It was unclear who or what was to blame for the mix-up in dosage. The origins of the error were currently being investigated and turned in about how to avoid such mishaps in the future. Additional information is not expected as no follow up is expected from the Local Health Authority.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyskinesia, Nausea, Pallor, Presyncope, Tinnitus
Clinical narrative: 5 min after immunizations administered patient became pale and nauseous, eyes closed with jerking motion of arm, ringing in ears. Per MD "near syncope and brief episode of jerking". "Mom observed pallor. Patient always awake". Observed - symptoms improved, discharged in NAD at 5:30pm.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Erythema, Headache, Injected limb mobility decreased, Injection site swelling
Clinical narrative: Case number PHEH2015US016782, is an initial spontaneous report from a consumer received on 25 Aug 2015. This report refers to a 59-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 157004) intramuscularly on an unknown date. On 18 Aug 2015, the patient experienced rash, nosebleed, low blood pressure, feeling lightheaded and fever (101 F). On 21 Aug 2015, the patient was diagnosed with cellulitis which was treated with clindamycin. The outcome of the event cellulitis was condition improving and outcome of other events was not reported. Seriousness and causality was not reported. Seriousness of the event cellulitis was upgraded based on Novartis Important Medical Events list.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Case number PHEH2015US016782, is an initial spontaneous report from a consumer received on 25 Aug 2015. This report refers to a 59-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 157004) intramuscularly on an unknown date. On 18 Aug 2015, the patient experienced rash, nosebleed, low blood pressure, feeling lightheaded and fever (101 F). On 21 Aug 2015, the patient was diagnosed with cellulitis which was treated with clindamycin. The outcome of the event cellulitis was condition improving and outcome of other events was not reported. Seriousness and causality was not reported. Seriousness of the event cellulitis was upgraded based on Novartis Important Medical Events list.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Dizziness, Epistaxis, Hypotension, Pyrexia
Clinical narrative: Case number PHEH2015US016782, is an initial spontaneous report from a consumer received on 25 Aug 2015. This report refers to a 59-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 157004) intramuscularly on an unknown date. On 18 Aug 2015, the patient experienced rash, nosebleed, low blood pressure, feeling lightheaded and fever (101 F). On 21 Aug 2015, the patient was diagnosed with cellulitis which was treated with clindamycin. The outcome of the event cellulitis was condition improving and outcome of other events was not reported. Seriousness and causality was not reported. Seriousness of the event cellulitis was upgraded based on Novartis Important Medical Events list.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash
Clinical narrative: Case number PHEH2015US016782, is an initial spontaneous report from a consumer received on 25 Aug 2015. This report refers to a 59-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 157004) intramuscularly on an unknown date. On 18 Aug 2015, the patient experienced rash, nosebleed, low blood pressure, feeling lightheaded and fever (101 F). On 21 Aug 2015, the patient was diagnosed with cellulitis which was treated with clindamycin. The outcome of the event cellulitis was condition improving and outcome of other events was not reported. Seriousness and causality was not reported. Seriousness of the event cellulitis was upgraded based on Novartis Important Medical Events list.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac disorder, Dyspnoea, Echocardiogram abnormal, Fatigue, Incorrect route of drug administration
Clinical narrative: Felt out-of-breath and fatigued.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Felt out-of-breath and fatigued.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Axillary pain, Cardiac function test normal, Chest X-ray normal, Electrocardiogram normal, Metabolic function test normal
Clinical narrative: Severe right arm pain, followed by pain spreading from right axilla across right anterior chest wall and finally to left chest wall, with an increase of pain with chest expansion from respirations.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Severe right arm pain, followed by pain spreading from right axilla across right anterior chest wall and finally to left chest wall, with an increase of pain with chest expansion from respirations.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, X-ray normal
Clinical narrative: Pain in bicep of vaccinated arm approx 1.5" below vaccination site upon raising elbow away from body - not a pulled muscle. Dr. did not link to vaccination. Pain ongoing; specialist prescribed physical therapy which is helping but pain still occurs.  Oongoing.
Age: 20.0
Sex: F
Vaccine: HEPAB
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain to entire right arm, difficult to move right arm due to pain. Rates pain as 9 out of 10. (this was the arm injected). No redness, no swelling, no induration, no temperature difference, grip strength equal, capillary refill quick and equal. This was the patient's 3rd and final Twinrix dose.
Age: 30.0
Sex: M
Vaccine: TTOX
Symptoms: Dyskinesia, Insomnia
Clinical narrative: Unable to sleep, legs thrashing. Symptoms resolved after 24 hours. No treatment was sought.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Multiple sclerosis, Paraesthesia
Clinical narrative: Patient received the vaccine in the morning and that evening (time unknown) she had numbness and tingling in her feet and legs. Several doctor visits later on 8/6/15 she was diagnosed with multiple sclerosis.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Hypoaesthesia, Lumbar puncture, Multiple sclerosis, Nuclear magnetic resonance imaging brain
Clinical narrative: Patient received the vaccine in the morning and that evening (time unknown) she had numbness and tingling in her feet and legs. Several doctor visits later on 8/6/15 she was diagnosed with multiple sclerosis.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Patient received the vaccine in the morning and that evening (time unknown) she had numbness and tingling in her feet and legs. Several doctor visits later on 8/6/15 she was diagnosed with multiple sclerosis.
Age: 13.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Hypersensitivity, Oedema, Pruritus, Urticaria
Clinical narrative: PATIENT DEVELOPED ALLERGY, HIVES AND ITCHY SKIN EDEMA.  PATIENT END UP HOSPITALIZED TWICE FOR A TOTAL OF 7 DAYS. SHE WAS TREATED WITH ZYRTEC 10MG AND ATARAX.
Age: 13.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Hypersensitivity, Oedema peripheral, Pruritus, Urticaria
Clinical narrative: PATIENT DEVELOPED ALLERGY, HIVES AND ITCHY SKIN EDEMA.  PATIENT END UP HOSPITALIZED TWICE FOR A TOTAL OF 7 DAYS. SHE WAS TREATED WITH ZYRTEC 10MG AND ATARAX.
Age: 1.75
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Blood pH decreased, Cardiac arrest, Drug screen negative, Life support, Retching
Clinical narrative: Dr received phone call from ER at 9:46 am. Dr at ER states child presented to the ER via personal automobile. Mom states patient was gagging all night. Child was in cardiac arrest when she arrived in the ER at 8:16 am. Pediatric advanced life support protocol active for one hour using every cardiac drug per Dr.
Age: 1.75
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Urine ketone body present, pH urine normal
Clinical narrative: Dr received phone call from ER at 9:46 am. Dr at ER states child presented to the ER via personal automobile. Mom states patient was gagging all night. Child was in cardiac arrest when she arrived in the ER at 8:16 am. Pediatric advanced life support protocol active for one hour using every cardiac drug per Dr.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Bradycardia, Hypotension
Clinical narrative: This is a spontaneous report from a contactable consumer via a Company sales representative. A 17 years old male student received TRUMENBA on 30Aug2015 between 14:00 and 16:00, intramuscular in deltoid, at 0.5 ml single. No other vaccines were given. Medical history and concomitant medications were not provided. Adverse event following prior vaccination: none. Within 30 minutes of vaccine administration, the patient experienced bradycardia and low blood pressure. The patient was looked over by a physician there and was later taken to the emergency room (but it was unknown if he was admitted to the hospital). Events outcome was unknown.
Sex: M
Vaccine: PNC13
Symptoms: Chest discomfort, Pulmonary congestion
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on 06Aug2015. The patient medical history was not reported. The patient's concomitant medications were not reported. On 29Aug2015 the patient went to the pharmacist and complained of having chest tightness, flame and could not cough or expectorate. The outcome was unknown. The pharmacist further mentioned that after reading package insert he/she could not find where that would be serious adverse effect or side effect. The pharmacist wanted to know if it was possible that the vaccine administration could cause pneumonia or pneumonia like symptoms.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Blood culture negative, Blood test, Chest X-ray, Culture urine positive, Myasthenia gravis
Clinical narrative: This is a spontaneous report from a contactable physician. A 69 year-old male patient received on 26Feb2015 PREVNAR 13 (lot number J67646, expiry date 31Mar2016) intramuscular at 0.5 ml single. Relevant medical history included diabetes, hypertension and hyperlipidemia. Concomitant medications included duloxetine (manufacturer unknown) at 30 mg three times a day, LIBRIUM at 5 mg twice a day, losartan (manufacturer unknown) at 25 mg twice a day, amlodipine (manufacturer unknown) at 5 mg two times a day and metformin (manufacturer unknown) at 500 mg three times a day. The patient experienced aspiration pneumonia on an unspecified date in Jun2015, myasthenia gravis and respiratory failure on unknown date. The primary infection site of pneumonia was lungs. The serotyping was not done for that and she did not know the specific organism. The patient underwent lab data which included: blood culture performed before the vaccination on 18Jun2013 that was negative. Chest X ray on an unspecified date in 2014 with unknown result. Urine culture on 26May2015 showed Coagulase negative staphylococcus. The patient underwent blood work on 05Mar2015, 06Mar2015, 31Mar2015, 21Apr2015, 07May2015, 08May2015, 09May2015, 10May2015, 11May2015, 12May2015, 18May2015, 26May2015, 06Jun2015, 10Jun2015, 25Aug2015, 26Aug2015 and on 27Aug2015 all with unknown results. The patient had recovered from the pneumonia but he was still experiencing myasthenia gravis and the patient was receiving treatment for Myasthenia gravis that was currently stabilized. The outcome of respiratory failure was unknown. The physician did not know the predisposing factors for infection but it occurred at the same time the patient had the respiratory failure secondary to Myasthenia gravis. The doctor when asked if the failure of treatment thought to be due to the development of a resistance to the product stated no and further added that she did not think that the pneumonia was connected with it, the patient concern was that he developed the Myasthenia gravis. The physician stated that it was unknown if there was a reasonable possibility that the myasthenia gravis and aspiration pneumonia were related to the vaccine.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia aspiration, Respiratory failure
Clinical narrative: This is a spontaneous report from a contactable physician. A 69 year-old male patient received on 26Feb2015 PREVNAR 13 (lot number J67646, expiry date 31Mar2016) intramuscular at 0.5 ml single. Relevant medical history included diabetes, hypertension and hyperlipidemia. Concomitant medications included duloxetine (manufacturer unknown) at 30 mg three times a day, LIBRIUM at 5 mg twice a day, losartan (manufacturer unknown) at 25 mg twice a day, amlodipine (manufacturer unknown) at 5 mg two times a day and metformin (manufacturer unknown) at 500 mg three times a day. The patient experienced aspiration pneumonia on an unspecified date in Jun2015, myasthenia gravis and respiratory failure on unknown date. The primary infection site of pneumonia was lungs. The serotyping was not done for that and she did not know the specific organism. The patient underwent lab data which included: blood culture performed before the vaccination on 18Jun2013 that was negative. Chest X ray on an unspecified date in 2014 with unknown result. Urine culture on 26May2015 showed Coagulase negative staphylococcus. The patient underwent blood work on 05Mar2015, 06Mar2015, 31Mar2015, 21Apr2015, 07May2015, 08May2015, 09May2015, 10May2015, 11May2015, 12May2015, 18May2015, 26May2015, 06Jun2015, 10Jun2015, 25Aug2015, 26Aug2015 and on 27Aug2015 all with unknown results. The patient had recovered from the pneumonia but he was still experiencing myasthenia gravis and the patient was receiving treatment for Myasthenia gravis that was currently stabilized. The outcome of respiratory failure was unknown. The physician did not know the predisposing factors for infection but it occurred at the same time the patient had the respiratory failure secondary to Myasthenia gravis. The doctor when asked if the failure of treatment thought to be due to the development of a resistance to the product stated no and further added that she did not think that the pneumonia was connected with it, the patient concern was that he developed the Myasthenia gravis. The physician stated that it was unknown if there was a reasonable possibility that the myasthenia gravis and aspiration pneumonia were related to the vaccine.