chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: The patient developed a sudden onset of bilateral hamstring pain within seven days following the shingles vaccine administration 4/28/15. Left shoulder pain followed over the next two weeks with limited mobility in the left arm. During this time, the patient continued to develop weakness in the lower extremities with difficulty in gait function. The patient was unable to dress or shower without assistance due to pain and weakness. Myalgia and joint pain continued throughout the month of May and June. The patient saw an orthopedic physician on 5/11/15 for gait weakness and left shoulder joint pain. The patient received a steroid joint injection into the left shoulder. A return follow-up visit on 5/27/15 indicated lab work studies and physical therapy implementation. The physician diagnosis was noted to be "adhesive capsulitis left shoulder; myofascial pain, and hamstring tightness both lower extremities". On 6/4/15, the patient was seen at the Clinic and more lab studies were ordered. Other return visits for medical assessment followed 6/11/15, 6/17/15, and 7/14/15. On 7/14/15 a different orthopedic physician injected steroid injections into both shoulders for frozen shoulders and joint pain. The patient was prescribed Meloxicam on a daily basis. On 7/29/15, the patient was seen by a rheumatologist.  A confirmed diagnosis for rheumatoid arthritis was discussed with the patient. The patient was healthy prior to this event and was highly recognized as a referee in high school football for over thirty years. The rheumatologist said the patient would be unable to referee football this season. The rheumatologist said there was possible association of this condition/disease with the shingles vaccine in discussion with the patient. The patient was prescribed RA medication (Sulfasalazine) to be taken on a daily basis. Also, Methylpred pak was prescribed as needed for flare-up with joint pain and swelling. Prior to the 7/29/15 appointment, the patient had swelling and finger joint pain to the left and right hands. Each hand would swell approximately 2.5 times the size of the opposite hand. The events were separate and continued for at least ten days in each hand. These events happened during the months of June and July. Please note the patient reported no fever (> 100.4 degree F) anytime following vaccine administration.
Age: 1.06
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Raise rashes scattered all over the body - given PRELONE 15mg/tsp 1/2 tsp BID x 5 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: Approximately 6" x 3" redness, hard, warm to touch, mild itching.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, MMR, VARCEL
Symptoms: Balance disorder, Communication disorder, Decreased appetite, Sleep disorder, Speech disorder
Clinical narrative: Speech and communication issues, stopped eating, sleeping pattern changed, loss of balance. Stopped producing new words, stopped repeating words.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, MMR, VARCEL
Symptoms: Speech disorder developmental
Clinical narrative: Speech and communication issues, stopped eating, sleeping pattern changed, loss of balance. Stopped producing new words, stopped repeating words.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Swelling, Tenderness
Clinical narrative: Swelling; Redness on all of arm to elbow; Tenderness; Headache.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Headache
Clinical narrative: Patient state ongoing headache since receiving vaccine. Will not go away.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: About 12 hours after pneumonia shot, I began to get achy and had a fever of 101 degrees.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Skin warm, Swelling, Tenderness
Clinical narrative: Medium sized red rash, swollen and hot to the touch and tender to touch. Ache constant. Started 1 hour following vaccine. No treatment at time of report.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Presented to office with (L) arm redness going from site of injection to approx 3 cm above antecubital space. Also had large bruise at site. NP looked at site and prescribed BENADRYL PO 25mg Q8 hrs for 2 days.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Pharyngeal oedema
Clinical narrative: Patient returned to Health Center at 1:15 PM with complaint of throat feeling swollen since 11 AM. No shortness of breath/difficulty breathing. Vital signs stable. BENADRYL 50 mg IM given at 1:34 PM. Patient observed and reported resolution of throat swelling sensation.
Sex: U
Vaccine: PPV, TDAP
Symptoms: Localised infection, Movement disorder, Peripheral swelling
Clinical narrative: Swollen arms, was not able to move arm. Arm got infected. Had to be antibiotics for ten days (per patient on 11/16/15).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Skin warm
Clinical narrative: Severe pain in upper left arm; red from shoulder almost to elbow. Couldn't move arm for 2 days. Arm was warm to touch. No fever. Slowly resolved over approx. 6 days.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site pain, Laboratory test, Neck pain, Vomiting
Clinical narrative: Headache, neck pain 2 hours after injection. C/O (L) deltoid being sore. Next AM/day, vomiting.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of VAQTA (dose and route were not reported, lot # K004856 with expiration date: 07-DEC-2016; lot # L004743 with expiration date: 01-JUN-2017; lot # K012457 with expiration date: 04-JUN-2017) which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative and refers to a 67 year old patient (gender was not specified). The patient's pertinent medical history or drug allergies/drug reactions were not reported. On 11-NOV-2015, the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, dose, route of administration and anatomical location were not reported). There was no concomitant medication reported. On 11-NOV-2015, the patient experienced injection site reaction, injection site swelling, injection site warmth and injection site erythema that resolved in 2 days (13-NOV-2015). There was no product quality issue involved. At the reporting time, the outcome of injection site reaction, injection site swelling, injection site warmth and injection site erythema was reported as recovered on 13-NOV-2015. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Gait disturbance, Tenderness
Clinical narrative: This spontaneous report was received from a physician and a nurse, via a company representative, referring to a 2 year old male patient. The patient's concurrent conditions and medical history were not provided. The patient did not have any drug reactions/allergies. On unknown days in February 2015 and March 2015, the patient was vaccinated with PREVNAR13, administration route, lot, expiration date and dose unknown. On 09-APR-2015 the patient was vaccinated with a dose of PNEUMOVAX23, administration route and dose unknown (lot # K020215, expiration date was not reported). After receiving the dose of PNEUMOVAX23, on an unknown date in APRIL 2015, the patient experienced tenderness in his leg,  he also could not walk on his leg after he received the vaccine and the leg was also red. It was reported that no treatment was given for the event and no laboratory tests were performed. At the time of this report, the outcome of the events were reported as recovered on an unknown date in 2015. 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 licensed practical nurse (L.P.N.) referring to unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with doses of GARDASIL (dose and route of administration were not reported) (Lot # K006960, expiration date: 24-FEB-2017; Lot# K007828, expiration date: 02-MAR-2017; Lot # K009482, expiration date: 06-MAR-2017), which were exposed to temperatures outside of the recommended range. No adverse experiences have been reported. There was no product quality complaint (PQC) involved. This is one of the 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 was received from a licensed practical nurse (L.P.N.) referring to unspecified number of patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with doses of PROQUAD (Merck) (dose and route of administration were not reported) (Lot # K021548, expiration date: 06-MAY-2016; Lot# K022447, expiration date: 13-MAY-2016; Lot# L016395, expiration date: 8-NOV-2016; Lot # L023112, expiration date: 24-DEC-2016; Lot # L030591, expiration date: 10-FEB-2017; Lot# L034931, expiration date: 03-MAR-2017), which were exposed to temperatures outside of the recommended range. No adverse experiences have been reported. There was no product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site warmth, Nausea
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unspecified age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date in 2010, the patient had previously received PNEUMOVAX 23 (Manufacturer unknown). On 19-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, (lot # L003188, expiry 06-JUL-2016) in the right deltoid along with FLUZONE (lot number UI443AD) in the left deltoid. The left arm was free of injection site reaction. Concomitant medications were not reported. Beginning on unknown date approximately in 2015, patient experienced redness from injection site of right deltoid to elbow. This area was warm and sensitive to touch. Additionally the patient had nausea. The patient took TYLENOL for symptoms. The patient was seen on 22-OCT-2015. At time of visit, events were resolving and it was unknown if events completely resolved. The nurse considered the events to be related to this specific lot of PNEUMOVAX 23. She further stated that lot # L003188 had been returned by the health department to the vendor. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via field representative referring to a female patient of unknown age. The physician stated that this was a new patient whose previous physician had retired, and therefore the physician was not familiar with the patient's medical history. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose and lot# were unknown) for prevention of shingles. On an unknown date the patient developed shingles under her left arm, and it spread to her chest. The patient saw the physician for medical attention and was treated with unspecified pain medication. The outcome of the event was reported as recovering/resolving. The causality was not reported. Additional information is not expected as the reporter didn't like to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates these patients were vaccinated with improperly stored doses of ROTATEQ (lot # K015816 with expiration 29-MAY-2016; dose and frequency were not reported) orally. No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Acne, Injection site erythema, Rash erythematous, Urticaria
Clinical narrative: Inoculation: (L) arm. No symptom of fever. No reaction on 1st day. Next day red spot on (R) foot, followed next day a bigger one above it. Also, on (L) arm, below inoculation, a 3 1/2 in. red spot, and smaller ones on (R) arm above and below elbow. On Sept. 17 saw Dermatologist. Use: Clobetasol for 2 wk. Spots begin disappear when I again saw DA, Oct 8, and said use only CERAVE cream moisturizer for 2 wk. Then on Oct 27 saw Dr. in same office. By then, some spots were partially clearing, and said use triamcinolone for 2 wk. Today Nov. 18 - 3 months from day of inoculation - some red spots still continue, but not worse. The large one in the (L) arm, is still there, but, lighter and broken down in smaller parts. Hives, string of low key pimples, did appear also after 1 wk. or so after inoculation, in the lower back and in both legs. They usually start to disappear after applying of corticosteroids. The first spots below and on the ankle and adjacent area have almost disappeared after first two weeks. Since then I have only applied CERAVE. I will be 87 at end of this year. I have had vaccine shots of all kinds during my lifetime, without any reactions. Maybe my present reaction to PCV-13 is rare, even so for dermatologists, so are not up to par with the proper treatment. Seven years ago I was inoculated with the regular bacterial pneumonia vaccine without any complication. And 14 years ago I came down with a bacterial pneumonia. My blood type is AB positive. I have a tuberculosis antibody, or antigen, in my system, as a result to an exposure of that ailment while out of the country before 1970. If you can recommend another form of treatment for the PCV-13 allergy, I would appreciate your advice, thank you. It's already 3 months since the PCV-13 shot and some spots still linger, and some few new pimples appear on arms and legs. Will see again Dr. Dec. 15.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, strength and frequency not reported, lot # L013826, expiry date: 21-APR-2017). No adverse effects were reported. This case is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, refers to an unknown number of patients, of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly doses of ROTATEQ, oral, (lot#, expiration date, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects reported. No product quality complain was involved. This is one of 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 as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patient were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L015048 with exp. 29-APR-2017, (route and dose were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
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. Ages, genders, medical history or concurrent conditions were reported. Since 08-SEPT-2015, an unspecified number of improperly stored doses of ROTATEQ (lot # L013188), were inadvertently administered to an unspecified number of patients. No adverse effects have been reported. The reporter refers that was not product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2015US015711, is a combined initial and follow-up spontaneous report from a health care professional received on 10 Aug 2015 and 11 Aug 2015, with the follow-up received on 02 Oct 2015. This report refers to a patient of an unknown age and gender. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with MENVEO (batch number: X15031) without being reconstituted with MenA lyophilized conjugate component on an unknown date. No adverse event was reported following the administration error. Reporter stated that this report was reported to her by the patient's mother. Reporter was not the one administering the medication, it was done at the provider's office. Reporter does not have any additional information about the patient or about what happened and is not able to assist with additional information. Follow-up received from the health care professional on 02 Oct 2015: Updated reporter comments.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 17-AUG-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L013068 with exp. 14-APR-2017, (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, refers to an unknown number of patients, of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored doses of COMVAX (lot #, expiration date, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects reported, product quality complain was no involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, referring to a 65 year old female patient. The patient's medical history and concurrent condition were not reported. On 05-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous in the arm (lot #, expiration date and dose was not reported). Concomitant was not reported. ON 05-OCT-2015, after being administered ZOSTAVAX "her entire arm was swollen" (peripheral swelling). The patient sought medical attention as she visited the doctor's office and was treated with BENADRYL. The outcome of peripheral swelling was reported as recovered on unspecified date. There were no lab diagnostics performed. Tke relatedness between peripheral swelling and ZOSTAVAX was unknown . 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 register nurse, refers to an unknown number of patients, of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly doses of RECOMBIVAX HB (lot#, expiration date, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects reported. No product quality complaint was involved. This is one of 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 as received from a nurse practitioner refers to a patient of unknown age and gender. On 14-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L013068 with exp. 14-APR-2017, (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose, route, lot # and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPAB
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a other health processional and described the occurrence of therapy non-responder in a adult patient who received HAB. Co-suspect products included HAB and HAB.  On an unknown date, the patient received the 1st dose of HAB, the 2nd dose of HAB, and the 3rd dose of HAB. On an unknown date, an unknown time after receiving HAB and HAB and 7 days after receiving HAB, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was  unknown. It was unknown if the reporter considered the therapy non-responder to be related to HAB, HAB and HAB. Additional details were provided as follows: This case was reported by a medical assistant. The patient was following an accelerated schedule of HAB, with the intention of starting HUMARA. One week after receiving the 3rd dose of HAB, the patient underwent laboratory test which revealed negative titers for hepatitis A and B antibodies. Thus, the patient became a therapy non-responder. This case was received via Merck National Service Center. No further information was provided.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot number was reported as "K007264" with exp. "02-MAR-2017", (dose and route were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Throat irritation, Vocal cord disorder
Clinical narrative: At approx 5:20pm she felt scratchy, irritated throat and vocal cords while working. Went home and felt worse. Went to ER and was given oral prednisone and prescription for 5 more days of oral prednisone. She states she was in the hospital 2-2 1/2 weeks earlier and received injection to thin her blood for A-fib.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, lot # L008057 exp. 01-DEC-2016, (dose and route were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, in November 2015, was administered to the patient an expired dose of ZOSTAVAX (lot # K010967, expiry date 06-NOV-2015). Other co-suspect or concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (dose and route were not reported, lot # K008334 with expiration date: 09-JUN-2016; lot # K022265 with expiration date: 22-OCT-2016) which were exposed to temperature outside of the recommended range. No adverse experience was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX23 (dose and route were not reported, lot # K008927 with expiration date: 17-MAR-2016; lot # K018528 with expiration date: 14-APR-2016) which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a 77 year old female consumer referring to herself. The patient's medical history included breast cancer. The patient had no drug reactions/allergies. Information about concurrent conditions was not reported. On 02-MOV-2015, the patient was vaccinated with PNEUMOVAX23, intramuscularly, 1 dose, once, lot # K021030, expiration date JUNE 2022. Concomitant therapies included anastrozole (manufacturer unknown) and hydrochlorothiazide (manufacturer unknown). On 02-NOV-2015, within the hour of administration of PNEUMOVAX23 the patient experienced injection site swelling, redness and pain. The patient did not seek medical attention. The treatment reported, was that the patient put ice on it. Laboratory diagnostics were not performed. The outcome of the events was reported as recovered, also reported as: the symptoms were absorbed and decreased within 3-4 days, approximately on 06-NOV-2015. The reporter did not assess the relatedness from injection site swelling, redness and pain to PNEUMOVAX23. Additional information is not expected as reporter details were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No medical history or concurrent conditions were reported. The reporter stated that the patient received his first dose of ZOSTAVAX on 11-DEC-2013. However, on 18-NOV-2015, the patient was inadvertently administered a second dose of ZOSTAVAX with lot # L021602 and expiry date 10-SEP-2016. No concomitant therapies were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, lot # and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (unknown route and strength) lot # L000610 with expiry date of 31-JAN-2017 or lot # L007560 with expiry date of 15-JUN-2017. No adverse effects were reported. The nurse confirmed that no vaccines were administered after the labeled expiration dates. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of  unknown age and gender. On 05-NOV-2015 the patient was vaccinated with improperly stored ZOSTAVAX (lot # L003216, expiration date 30-APR-2016, strength, dose and route were unknown). NO adverse effect was reported. This is one of 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 as received from a nurse practitioner refers to a patient of unknown age and gender. On 21-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L013068 with exp. 14-APR-2017, (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Neck pain, Peripheral swelling
Clinical narrative: Reported swelling in left arm and left neck with continued pain in left neck for 6 months afterward. Symptoms started within 24 hours of receiving shot in left arm.
Age: 1.4
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning a 16 month old patient (gender not reported) who on 05-NOV-2015 (also reported as "today"), was vaccinated with an expired dose of (Oka/Merck VARIVAX (lot no. J012210, exp. 28-SEP-2015) (route and site not reported). No adverse event was reported. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Cellulitis, Erythema, Tenderness
Clinical narrative: This unsolicited case was received on 10 November 2015 via a third party query tool search on the VAERS database, under reference number 584193. A 20-year-old male patient received the following vaccinations on 13 June 2015: first dose of ACAM2000 (lot number was not reported, manufacturer: Sanofi Pasteur Biologics Co.) route was reported as "intradermal" in the left arm, a dose of BIOTHRAX (lot number: FAV427A, manufacturer: Emergent) in the right arm. The patient's medical history, current illnesses and other medications were reported as none. The prior vaccination detail was not reported. On 21 June 2015, 8 days post-vaccination, the patient developed red strip and tenderness of skin near the shot area and cellulitis. The patient required emergency visit. Laboratory investigation was not performed. The patient received unspecified medicine for cellulitis as a corrective treatment. The outcome of the event was unknown. Upon internal review, company assessed the event of cellulitis as serious and important medical event. List of documents held by sender: none.
Sex: U
Vaccine: MENB, MENB
Symptoms: Back pain, Chest pain, Chills, Myalgia, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician as received via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced patient chills that lasted 24 hours on an unspecified date with outcome of unknown.
Sex: U
Vaccine: MENB, MENB
Symptoms: Chills
Clinical narrative: This is a spontaneous report from a contactable physician as received via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced patient chills that lasted 24 hours on an unspecified date with outcome of unknown.
Age: 19.0
Sex: M
Vaccine: FLUX, MENB, FLUX, MENB
Symptoms: Culture throat, Erythema, Headache, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for her son. A 19-year-old male patient received third dose of TRUMENBA, via an unspecified route of administration on 08Sep2015 at single dose. The patient medical history was not reported. Concomitant medication included influenza vaccine given on 08Sep2015. Previously maybe on Jan2015 he took first dose of meningococcal group b and three months later (Apr2015, in the spring) his second shot. He took flu shot every year for probably the past eight years. He had no adverse events before with these shots. On 08Sep2015 about twelve hours after he received the vaccine, patient experienced a severe reaction :he felt sick, he was severely ill, had fever at 102 or higher, headache, nausea, neck pain, achiness and diarrhea. His symptoms worsened and patient also reported his headache was worse than severe. The final outcome of the events was not recovered. Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: M
Vaccine: FLUX, MENB, FLUX, MENB
Symptoms: Pain, Pyrexia, Streptococcus test negative, Tenderness
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for her son. A 19-year-old male patient received third dose of TRUMENBA, via an unspecified route of administration on 08Sep2015 at single dose. The patient medical history was not reported. Concomitant medication included influenza vaccine given on 08Sep2015. Previously maybe on Jan2015 he took first dose of meningococcal group b and three months later (Apr2015, in the spring) his second shot. He took flu shot every year for probably the past eight years. He had no adverse events before with these shots. On 08Sep2015 about twelve hours after he received the vaccine, patient experienced a severe reaction :he felt sick, he was severely ill, had fever at 102 or higher, headache, nausea, neck pain, achiness and diarrhea. His symptoms worsened and patient also reported his headache was worse than severe. The final outcome of the events was not recovered. Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: M
Vaccine: FLUX, MENB, FLUX, MENB
Symptoms: Diarrhoea, Headache, Malaise, Nausea, Neck pain
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for her son. A 19-year-old male patient received third dose of TRUMENBA, via an unspecified route of administration on 08Sep2015 at single dose. The patient medical history was not reported. Concomitant medication included influenza vaccine given on 08Sep2015. Previously maybe on Jan2015 he took first dose of meningococcal group b and three months later (Apr2015, in the spring) his second shot. He took flu shot every year for probably the past eight years. He had no adverse events before with these shots. On 08Sep2015 about twelve hours after he received the vaccine, patient experienced a severe reaction :he felt sick, he was severely ill, had fever at 102 or higher, headache, nausea, neck pain, achiness and diarrhea. His symptoms worsened and patient also reported his headache was worse than severe. The final outcome of the events was not recovered. Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: M
Vaccine: FLUX, MENB, FLUX, MENB
Symptoms: Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for her son. A 19-year-old male patient received third dose of TRUMENBA, via an unspecified route of administration on 08Sep2015 at single dose. The patient medical history was not reported. Concomitant medication included influenza vaccine given on 08Sep2015. Previously maybe on Jan2015 he took first dose of meningococcal group b and three months later (Apr2015, in the spring) his second shot. He took flu shot every year for probably the past eight years. He had no adverse events before with these shots. On 08Sep2015 about twelve hours after he received the vaccine, patient experienced a severe reaction :he felt sick, he was severely ill, had fever at 102 or higher, headache, nausea, neck pain, achiness and diarrhea. His symptoms worsened and patient also reported his headache was worse than severe. The final outcome of the events was not recovered. Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (who reported for his son) and contactable physician. A 19-years-old male patient received the second dose of TRUMENBA, via an unspecified route of administration on 02Aug2015, at 0.5 ml single dose. The patient received the first dose of the same vaccine 40 to 70 days before this one. The patient medical history was not reported. There were no concomitant medications. The patient experienced swelling around the eyes and swelling around the vaccination location on an unspecified date with outcome of unknown with both doses received. Follow up (28Sep2015): Additional information received from a contactable physician includes date of vaccination.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Eye swelling, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (who reported for his son) and contactable physician. A 19-years-old male patient received the second dose of TRUMENBA, via an unspecified route of administration on 02Aug2015, at 0.5 ml single dose. The patient received the first dose of the same vaccine 40 to 70 days before this one. The patient medical history was not reported. There were no concomitant medications. The patient experienced swelling around the eyes and swelling around the vaccination location on an unspecified date with outcome of unknown with both doses received. Follow up (28Sep2015): Additional information received from a contactable physician includes date of vaccination.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 69-year-old male patient received PREVNAR 13 (lot L87117, expiry date Feb2017, NDC number: 0005197102) intramuscularly in the left deltoid on 24Sep2015 at 10:00 at 0.5 ml single dose and FLUZONE HD (Sanofi Pasteur, lot UI442AA, expiry date 06Apr2016) intramuscularly on the right deltoid on 24Sep2015 (time unspecified) at single dose. Relevant medical history and concomitant medications were not reported. The patient, one year before this report, received flu shot (high dose) and he had no problem. The patient experienced tingling in hands and muscle weakness all over on 24Sep2015 at 3 pm. The patient went to the emergency room (as recommended by the pharmacist that was afraid of Guillain Barre) but he was not hospitalized. The pharmacist considered the events serious. Unspecified tests were performed in the emergency room. The patient recovered from the events on 28Sep2015. The pharmacist believed the events were possible related to the PREVNAR 13. Suspected relationship was ruled out eventually by emergency room physician. Follow-up (12Nov2015): New information received from the same contactable pharmacist includes: event details, seriousness, co-suspect, comment. Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Laboratory test, Muscular weakness, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 69-year-old male patient received PREVNAR 13 (lot L87117, expiry date Feb2017, NDC number: 0005197102) intramuscularly in the left deltoid on 24Sep2015 at 10:00 at 0.5 ml single dose and FLUZONE HD (Sanofi Pasteur, lot UI442AA, expiry date 06Apr2016) intramuscularly on the right deltoid on 24Sep2015 (time unspecified) at single dose. Relevant medical history and concomitant medications were not reported. The patient, one year before this report, received flu shot (high dose) and he had no problem. The patient experienced tingling in hands and muscle weakness all over on 24Sep2015 at 3 pm. The patient went to the emergency room (as recommended by the pharmacist that was afraid of Guillain Barre) but he was not hospitalized. The pharmacist considered the events serious. Unspecified tests were performed in the emergency room. The patient recovered from the events on 28Sep2015. The pharmacist believed the events were possible related to the PREVNAR 13. Suspected relationship was ruled out eventually by emergency room physician. Follow-up (12Nov2015): New information received from the same contactable pharmacist includes: event details, seriousness, co-suspect, comment. Follow-up attempts completed. No further information expected.
Age: 11.0
Sex: M
Vaccine: MENB, MNQ, TDAP, MENB, MNQ, TDAP
Symptoms: Decreased appetite, Dizziness, Erythema, Headache, Induration
Clinical narrative: This is spontaneous report from a contactable other healthcare professional who reported similar events for three patients and from a physician. This is the first of three reports. A 11-year-old  male patient received TRUMENBA (lot number L13514, expiration date Jul2016, NDC number 0005010010) on 07Oct2015 around 3:25 pm at 0.5 ml single dose intramuscular in the right deltoid. On the same date, the patient received also BOOSTRIX (manufactured by Glaxo, lot number 74NT9) intramuscular in the left deltoid and MCV4 (Novartis, lot number M15032) intramuscular in left deltoid. Relevant medical history and concomitant medications were not reported. No illness at time of vaccination. On 07Oct2015, about 30 minutes after vaccine administration, the patient experienced headache, inability to move the arm, induration, erythema and dizziness. In Oct2015 the patient experienced edema, vomiting and loss of appetite. The patient was not hospitalized. The outcome of the events was unknown. Follow up (08Oct2015): New information received from the same contactable Healthcare professional includes: patient and product details, concomitant vaccines, additional events (induration and erythema) onset date.
Age: 11.0
Sex: M
Vaccine: MENB, MNQ, TDAP, MENB, MNQ, TDAP
Symptoms: Mobility decreased, Vomiting
Clinical narrative: This is spontaneous report from a contactable other healthcare professional who reported similar events for three patients and from a physician. This is the first of three reports. A 11-year-old  male patient received TRUMENBA (lot number L13514, expiration date Jul2016, NDC number 0005010010) on 07Oct2015 around 3:25 pm at 0.5 ml single dose intramuscular in the right deltoid. On the same date, the patient received also BOOSTRIX (manufactured by Glaxo, lot number 74NT9) intramuscular in the left deltoid and MCV4 (Novartis, lot number M15032) intramuscular in left deltoid. Relevant medical history and concomitant medications were not reported. No illness at time of vaccination. On 07Oct2015, about 30 minutes after vaccine administration, the patient experienced headache, inability to move the arm, induration, erythema and dizziness. In Oct2015 the patient experienced edema, vomiting and loss of appetite. The patient was not hospitalized. The outcome of the events was unknown. Follow up (08Oct2015): New information received from the same contactable Healthcare professional includes: patient and product details, concomitant vaccines, additional events (induration and erythema) onset date.
Age: 11.0
Sex: M
Vaccine: MENB, MNQ, TDAP, MENB, MNQ, TDAP
Symptoms: Mobility decreased, Oedema, Vomiting
Clinical narrative: This is spontaneous report from a contactable other healthcare professional who reported similar events for three patients and from a physician. This is the first of three reports. A 11-year-old  male patient received TRUMENBA (lot number L13514, expiration date Jul2016, NDC number 0005010010) on 07Oct2015 around 3:25 pm at 0.5 ml single dose intramuscular in the right deltoid. On the same date, the patient received also BOOSTRIX (manufactured by Glaxo, lot number 74NT9) intramuscular in the left deltoid and MCV4 (Novartis, lot number M15032) intramuscular in left deltoid. Relevant medical history and concomitant medications were not reported. No illness at time of vaccination. On 07Oct2015, about 30 minutes after vaccine administration, the patient experienced headache, inability to move the arm, induration, erythema and dizziness. In Oct2015 the patient experienced edema, vomiting and loss of appetite. The patient was not hospitalized. The outcome of the events was unknown. Follow up (08Oct2015): New information received from the same contactable Healthcare professional includes: patient and product details, concomitant vaccines, additional events (induration and erythema) onset date.
Age: 19.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Back pain, Blood creatine phosphokinase increased, CSF protein increased, Full blood count normal, Guillain-Barre syndrome
Clinical narrative: Lower back pain and numbness in feet bilaterally.
Age: 19.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Metabolic function test normal, Muscular weakness, Paraesthesia
Clinical narrative: Lower back pain and numbness in feet bilaterally.
Age: 19.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Back pain, Computerised tomogram, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Lower back pain and numbness in feet bilaterally.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever 103, Fatigue.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Full blood count, Injection site erythema, Injection site pruritus, Injection site swelling, Nuclear magnetic resonance imaging
Clinical narrative: Excessive swelling and redness at site with itchiness   Tylenol icepack Claritin/Benadryl.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Excessive swelling and redness at site with itchiness   Tylenol icepack Claritin/Benadryl.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fatigue, fever (101.5).