chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blepharospasm, Facial pain, Herpes zoster, Malaise, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to currently 71 year old male patient. Pertinent medical history and drug allergic reactions were none. Approximately in 2005 (almost 10 years ago), the patient was vaccinated with ZOSTAVAX (unknown route and dose) for prevention of shingles. Concomitant medications were none. The patient was seen in an unspecified emergency room on 12-APr-2015 due to pain in the back of his legs accompanied by mild rash on the back of legs, left eye and mouth drooping, right eye twitching and pain in face. All symptoms had started on an unspecified date and the patient was diagnosed with mild shingles and Bell's palsy. The patient was not hospitalized but went to Emergency Room because he wasn't feeling well. Lab diagnostic studies were none. The patient was treated with prednisone (unknown dose) for 5 days and acyclovir (unknown dose) for 10 days. The patient was discharged from the unspecified emergency room on an unknown date. The outcome of Bell's palsy was not recovered and the outcome of mild shingles was recovered on an unknown date in 2015 as the patient "no longer has shingles-like symptoms" but "still has the Bell's palsy-like symptoms". The outcome of the event wasn't feeling well was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a pharmacist refers to currently 71 year old male patient. Pertinent medical history and drug allergic reactions were none. Approximately in 2005 (almost 10 years ago), the patient was vaccinated with ZOSTAVAX (unknown route and dose) for prevention of shingles. Concomitant medications were none. The patient was seen in an unspecified emergency room on 12-APr-2015 due to pain in the back of his legs accompanied by mild rash on the back of legs, left eye and mouth drooping, right eye twitching and pain in face. All symptoms had started on an unspecified date and the patient was diagnosed with mild shingles and Bell's palsy. The patient was not hospitalized but went to Emergency Room because he wasn't feeling well. Lab diagnostic studies were none. The patient was treated with prednisone (unknown dose) for 5 days and acyclovir (unknown dose) for 10 days. The patient was discharged from the unspecified emergency room on an unknown date. The outcome of Bell's palsy was not recovered and the outcome of mild shingles was recovered on an unknown date in 2015 as the patient "no longer has shingles-like symptoms" but "still has the Bell's palsy-like symptoms". The outcome of the event wasn't feeling well was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to two unspecified patients of unknown age and gender. On unknown dates, the patients were inadvertently vaccinated with two doses of improperly stored ZOSTAVAX vial (lot # K010732, expiration date 10-OCT-2015, dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: HEPA
Symptoms: Colitis ulcerative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 54 year old male patient with drug reaction/allergy to codeine. Concomitant therapy and pertinent medical history were not reported. On an unspecified date in 2013, the patient was vaccinated with a dose of Hepatitis A vaccine (manufacturer unknown) (dose, lot#, indication, route of administration not reported). On an unknown date, the patient was diagnosed with ulcerative colitis. The pharmacist was unsure, if the patient was diagnosed prior to vaccination with Hepatitis A vaccine (manufacturer unknown) or after the vaccination). The pharmacist reported that, on an unspecified date, the patient was started on REMICADE "every 6-8 weeks" for the treatment of ulcerative colitis and the patient was still being treated with the REMICADE, at the time of the report. The patient sought medical attention in an unspecified way. The outcome of ulcerative colitis was unknown. The relatedness between ulcerative colitis and Hepatitis A vaccine (manufacturer unknown) was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker via a company representative referring to "one or two" unspecified patients. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength, lot#, expiration date, dose and route were unknown). On an unknown date "about a year later", the patients came back to received a second dose of GARDASIL (strength, lot#, expiration date, dose and route were unknown). The physician decided to "restart" the GARDASIL series (due to the amount of time that elapsed between the 1st and 2nd dose) therefore "one or two" unspecified patients received 4 doses of GARDASIL (all on unspecified dates). No adverse effect reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test, Gastric disorder, Headache, Immediate post-injection reaction, Lumbar puncture
Clinical narrative: This spontaneous report as received from a consumer (patient's father) refers to a 17-year-old male patient. There were no concurrent condition and medical history reported. The patient did not have allergy. On 03-OCT-2011, the patient was vaccinated with the first dose GARDASIL "one single shot" (route of administration, strength, lot number and expiration date were not reported). Concomitant therapies included FLUZONE (Sanofi Pasteur). On 03-OCT-2011, "immediately" after vaccination, the patient experienced headache. The patient has been seen by numerous specialists; he has been taken to the hospital, and spent a 17-day treatment program at the "Institute, in the fall of 2012,". The patient's father stated that his son has had "no relief" from the many unspecified medications he has been given as headache treatment; these medications "affected his sleep and caused stomach problems." However, patient's father also said that his son "had success" with unspecified IV medications, but this "wasn't matched with the other medications." The patient has been to the emergency room 3 times, where he would be given a "migraine cocktail that included (BENADRYL)" and stayed overnight one time (date unknown) at an unspecified hospital". Lab diagnostic studies included: magnetic resonance imaging (MRI), blood work and spinal puncture on an unknown date (results not provided). Therapy with GARDASIL was discontinued after receiving first injection (on 03-OCT-2011). The outcome of events was unknown. The relatedness between adverse events and therapy with GARDASIL was not reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Sleep disorder
Clinical narrative: This spontaneous report as received from a consumer (patient's father) refers to a 17-year-old male patient. There were no concurrent condition and medical history reported. The patient did not have allergy. On 03-OCT-2011, the patient was vaccinated with the first dose GARDASIL "one single shot" (route of administration, strength, lot number and expiration date were not reported). Concomitant therapies included FLUZONE (Sanofi Pasteur). On 03-OCT-2011, "immediately" after vaccination, the patient experienced headache. The patient has been seen by numerous specialists; he has been taken to the hospital, and spent a 17-day treatment program at the "Institute, in the fall of 2012,". The patient's father stated that his son has had "no relief" from the many unspecified medications he has been given as headache treatment; these medications "affected his sleep and caused stomach problems." However, patient's father also said that his son "had success" with unspecified IV medications, but this "wasn't matched with the other medications." The patient has been to the emergency room 3 times, where he would be given a "migraine cocktail that included (BENADRYL)" and stayed overnight one time (date unknown) at an unspecified hospital". Lab diagnostic studies included: magnetic resonance imaging (MRI), blood work and spinal puncture on an unknown date (results not provided). Therapy with GARDASIL was discontinued after receiving first injection (on 03-OCT-2011). The outcome of events was unknown. The relatedness between adverse events and therapy with GARDASIL was not reported. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: Fever this am 101F. Reaction site redness. Borders drawn site 5" x 3 3/4" redness swelling body aches, nausea.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On 13-MAY-2015, the patients were vaccinated with oral, ROTATEQ (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On 13-MAY-2015, the patient experienced incorrect product storage as improperly stored doses of oral, ROTATEQ were administered to them. No adverse event. It was unknown if the patients sought medical attention. At the time of this report, the patients' status was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Cellulitis, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Evening of injections pt had red, hot, swelling to (R) deltoid area. Extended from shoulder to elbow. 3 blistered areas near injection sites. Possible infection. Prescribed Cetirizine and cephalexin for allergic reaction and cellulitis.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Evening of injections pt had red, hot, swelling to (R) deltoid area. Extended from shoulder to elbow. 3 blistered areas near injection sites. Possible infection. Prescribed Cetirizine and cephalexin for allergic reaction and cellulitis.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt was administered vaccine by Rph. Pt came 06/03/15 with erythema and warmth by injection area. Pt went to dr. Dr prescribed him DURICEF.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date excursion occurred), the patient was vaccinated with a dose of PROQUAD (Merck) (dose and route were not reported), which underwent supported temperature excursions. The patient might have received the following lot numbers and expiration dates of PROQUAD (Merck): lot# L002419 with expiration date 23-JUL-2016 or lot# reported as L005293 with expiration date 17-AUG-2016. No adverse effects were reported. No PQC (product quality complaint) was involved. 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 as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of PROQUAD (Merck) (dose and route were not reported), which underwent supported temperature excursions. The patient might have received the following lot numbers and expiration dates of PROQUAD (Merck): lot# L002419 with expiration date 23-JUL-20165 or lot# reported as L005293 with expiration date 17-AUG-2016. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt was administered vaccine by Rph on 6/01/15, on 6/3/15 pt returns to pharmacy with erythema and warmth around injection site.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Swelling, erythema, rest, ice. Pain (L) upper extremity elevation. Pain meds, AUGMENTIN 875-125 bid 10 days.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On 13-MAY-2015, the patients were vaccinated with RECOMBIVAX HB (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On 13-MAY-2015, the patients experienced incorrect product storage as improperly stored doses of RECOMBIVAX HB were administered to them. No adverse event. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Additional information has been requested. This is one of several reports received from the same source.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Administration site swelling, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Subjective fever, not quantified; redness, tenderness and swelling at sight of administration.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Pain at injection site, rash.
Age: 0.78
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a nurse and refers to a  20 year old female patient with no medical history and drug reactions or allergies. Approximately in September 1994, the patient was vaccinated with first dose of RECOMBIVAX HB 2.5/0.5 (units not provided) injection (lot#, expiration date, dose, route and site of vaccination were not reported). On 30-NOV-1994, the patient was vaccinated with second dose of RECOMBIVAX HB 2.5/0.5 (units not provided) injection (lot# 612506/0956A, expiration date 27-MAY-1997, dose route and site of vaccination were not reported). On 08-JUL-1995, the patient was vaccinated with third dose of RECOMBIVAX HB 2.5/0.5 (units not provided) injection (lot# 613926/0516B, expiration date 28-JUL-1997, dose, route and site of vaccination were not reported). Concomitant therapies included NASONEX. On 19-MAY-2015, the patient had negative titers. On 20-MAY-2015, as a treatment, the patient received first dose of repeat vaccination series of RECOMBIVAX HB 2.5/0.5 (units not provided) injection (lot#, expiration date, dose, route and site of vaccination were not reported). The outcome of the event was unknown. The patient sought medical attention and saw the physician. The relatedness between the event and RECOMBIVAX HB was not reported. 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 licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with improperly stored VARIVAX (Merck) (route of administrations, doses, lot numbers and expiry dates were not reported). It was reported that the vaccines were exposed to worst case 85F for 42.5 hours. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Blood culture negative, Pain, Pyrexia, Swelling
Clinical narrative: Patient reports pain, swelling and fever within 12 hours of injection. Was evaluated in ER and fever documented 101. Admitted due to other co-morbidities.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with improperly stored ROTATEQ (route of administrations default as oral, doses, lot numbers and expiry dates were not reported). It was reported that the vaccines were exposed to worst case 85F for 42.5 hours. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: On 5/14/15 child received MMR #1 and VARIVAX #1 and Hep #1. Child presented to the Emergency room with a fever of 104 and an apparent febrile seizure.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Chest X-ray normal, Febrile convulsion, Pyrexia, Urine analysis normal
Clinical narrative: On 5/14/15 child received MMR #1 and VARIVAX #1 and Hep #1. Child presented to the Emergency room with a fever of 104 and an apparent febrile seizure.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Local reaction to vaccine: redness and swelling. Treat with reassurance, cool compresses.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Rash generalised
Clinical narrative: Left upper arm with redness and swelling around site of injection for 24-36 hours after injection. Fine follicular rash over entire body and face starting 3 days after, injection and lasting 2 days.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an approximately 7 years old female (child) patient. The patient's medical history and concurrent conditions were not reported. On 18-DEC-2014, the patient was vaccinated with the first dose of VAQTA "Lot number K18181 has been verified to be an invalid lot number for VAQTA" and on 05-MAY-2015, the patient received the second dose of VAQTA, 0.5 ml, intramuscular in the right arm both doses (Inappropriate schedule of drug administration). The patient's concomitant therapies were not reported. No adverse effects were reported. Product quality complaints were not involved. Additional information is not expected since not permission to contact was given.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with improperly stored M-M-R II (route of administrations, doses, lot numbers and expiry dates were not reported). It was reported that the vaccines were exposed to worst case 85F for 42.5 hours. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist referring to a 17 year old female patient. Patient's concurrent conditions and medical history were not provided. On 31-DEC-2008, the patient was vaccinated with the first dose of GARDASIL (dose, lot #, expiration date and route were not reported). Three months later on 03-APR-2009, second dose of GARDASIL (dose, lot #, expiration date and route were not reported), and the third dose of GARDASIL (dose, lot #, expiration date and route were not reported) was administered on 01-JUN-2009, two months after. The patient had not reported or demonstrated an adverse experience, subsequently the vaccine administration. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with improperly stored PNEUMOVAX23 (route of administrations, doses, lot numbers and expiry dates were not reported). It was reported that the vaccines were exposed to worst case 85F for 42.5 hours. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 18 year old female patient. None pertinent medical history and concurrent conditions were reported. At the time of this report the patient had none drug reactions or allergies, and the patient was not pregnant. On 25-MAY-2015 the patient was vaccinated with a dose of M-M-R II, subcutaneous, Lot # L003855, expiration date 05-FEB-2017 (dose number and anatomical location were not reported). Concomitant therapies were unspecified. On 26-MAY-2015, the patient experienced injection site irritation, injection site warmth and injection site warmth and injection site erythema. The patient sought medical attention so she went to see the pharmacist. No treatment was given for the events. No lab diagnostics were performed. The outcome of the events was reported as not recovered. The relatedness between the events and M-M-R II was not reported. Lot number L003855 has been verified to be a valid lot number for M-M-R II. 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 vocational nurse and refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with improperly stored GARDASIL (route of administrations, doses, lot numbers and expiry dates were not reported). It was reported that the vaccines were exposed to worst case 85F for 42.5 hours. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Coma, Hemiplegia, Mobility decreased, Wheelchair user
Clinical narrative: Initial unsolicited report received from non-healthcare professional (media monitoring reports) on 28 May 2015. A 23-year-old female patient, whose concomitant medication was not reported, had received a dose of Influenza vaccine (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. Patient's medical history was reported as autoimmune disease known as acute disseminated encephalomyelitis. The condition had left her with lesions on her brain and spinal cord. On an unspecified date, three months after vaccination, patient had lapsed into a coma and never fully recovered. She was in a wheelchair and had difficulty moving the left side of her body as she was left paralyzed. Laboratory investigation and corrective treatment were not reported. At the time of this report, outcome of the event coma was not reported and patient was not recovered from the event of left sided paralysis. Upon medical review, company assessed the event of lapsed into a coma and paralyzed/difficulty moving the left side of her body as serious and important medical events. List of documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Coma, Mobility decreased, Paralysis, Wheelchair user
Clinical narrative: Initial unsolicited report received from non-healthcare professional (media monitoring reports) on 28 May 2015. A 23-year-old female patient, whose concomitant medication was not reported, had received a dose of Influenza vaccine (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. Patient's medical history was reported as autoimmune disease known as acute disseminated encephalomyelitis. The condition had left her with lesions on her brain and spinal cord. On an unspecified date, three months after vaccination, patient had lapsed into a coma and never fully recovered. She was in a wheelchair and had difficulty moving the left side of her body as she was left paralyzed. Laboratory investigation and corrective treatment were not reported. At the time of this report, outcome of the event coma was not reported and patient was not recovered from the event of left sided paralysis. Upon medical review, company assessed the event of lapsed into a coma and paralyzed/difficulty moving the left side of her body as serious and important medical events. List of documents held by sender: none.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: Mild erythema, 5 x 5 cm area of induration at vaccine admin. site (L) deltoid.
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 25.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Pericardial disease, Troponin I increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This solicited case was received from the investigator in a trial on 22 May 2015. A 25-year-old male subject, with medical history of chest pain and headaches, had received the following vaccines on 14 April 2015: a dose of ACAM2000 and a dose of Typhoid Vi (lot numbers, route and sites of administration not reported) and on 31 March 2015: a dose of Anthrax vaccine and Japanese Encephalitis vaccine (manufacturers, lot numbers, routes and sites of administration not reported). The subject was diagnosed with unspecified disease of pericardium on 25 April 2015 and non-specific myocarditis on 28 April 2015 i.e. 11 days and 14 days respectively post-vaccination. On 26 April 2015, troponin I was abnormal with highest value of 06.37, electrocardiogram (ECG) was abnormal and echocardiogram was normal. The outcome of the events were not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Company causality is associated. Documents held by sender: None.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified numbers of patients of unknown age and gender. There was no information about pertinent medical history or drug reactions/allergies reported. Since 19-MAY-2015 doses of ZOSTAVAX (lot# L006380, expiration date 26-MAY-2016, dose, route were not provided), which were exposed to temperatures outside the recommended range, have been administered to unspecified patients on unspecified dates. Information about concomitant medication was not provided. No adverse effects were reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a physician refers to a 13 year old male patient. On an unknown date, the patient was vaccinated with 2 doses of GARDASIL (dose and route were not reported) prior to receiving GARDASIL 0.5 ml, intramuscularly on Monday evening 11-MAY-2015 as the third dose in his HPV vaccination series. On 11-MAY-2015 when the patient received the dose of GARDASIL the injection was painful. On 13-MAY-2015 the patient experienced injection site erythema, and injection site warms and injection site swollen to the size of a golf ball. Treatment was not given to the patient. Patient did not sought medical attention. At the time of report, the patient was fine. Action taken was not applicable. The outcome of events was reported as recovered/resolved. The reporter did not provide the causality between the event and the suspect therapy.  This is one of two reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash erythematous
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 60 year old female patient immunosuppressed. The patient's medical history included two cases of shingles. On 22-MAY-2015 the patient was vaccinated with ZOSTAVAX lot # L003217, expiration date 30-APR-2015, subcutaneous. Concomitant therapies included methotrexate. The nurse reported that the patient had many red spots with blisters (that were about 1.25 by 2 centimeters) after receiving ZOSTAVAX (on 22-MAY-2015). It was also reported that the patient had two cases of shingles prior to get the ZOSTAVAX, which is other-than-indicated in the Prescribing Information. No treatment was given for adverse events. No lab diagnostic studies were performed. The patient seek medical attention, visited the pharmacy. The outcome of rash macular and blister was reported as not recovered. The causality was not reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt has redness and swelling on site. Also 101.6 fever. Gave pt doxycycline monohydrate 100 mg 1 capsule BID for 7 days.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient developed redness at injection site. As patient remained in waiting area the redness increased and began to itch. I contacted the physician and applied diphenhydramine spray. Patient remained in pharmacy for 40 minutes. Redness and itching were the primary symptoms. No shortness of breath reported.
Sex: F
Vaccine: PPV
Symptoms: Disseminated intravascular coagulation, Extra dose administered, Finger amputation, Leg amputation, Splenectomy
Clinical narrative: This spontaneous report was received from Pfizer and was assigned manufacturer report number 2015130234 concerning a female patient of unknown age who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # not reported). It was reported that the patient received PNEUMOVAX 23 2 or 3 times. On an unknown date, the patient underwent a surgically removed spleen and experienced disseminated intravascular coagulation (DIC) and lost both legs-bka (below knee amputation) and six fingers. At the time of the report, the patient's outcome was unknown. Upon internal review DIC and surgically removed spleen were considered to be medically significant. This was originally reported by a physician. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash
Clinical narrative: Raised little tiny bumps on both legs (thighs). Mom states that it was worse on her left thigh.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Induration, Skin warm, Swelling
Clinical narrative: Moderate to Severe Swelling, red, hard, and hot to the touch, some mild blistering near center of spot, diameter of swelling 3 inches and increasing still a day later, treatment so far nothing but monitoring.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: PPSV23 given instead of PCV13.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Eyelid function disorder, Hypoaesthesia oral, VIIth nerve paralysis
Clinical narrative: Facial droop on right side, unable to blink right eye; numbness on right side of lip area.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient received a Prevnar vaccine on Saturday morning (May 30, 2015).  Her left arm was cleaned with an alcohol swab.  The injection was administered intramuscualrly in the left deltoid.  On 6/5/15 the patient notified the pharmacy that her arm was sore, swollen, red and warm to the touch.  I advised her to call her physician for consultation.
Age: 1.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Petechiae, Platelet count normal
Clinical narrative: Mild petechiae on his right cheek. We visited the doctor and did the blood test.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Burning sensation, Erythema, Rash, Rash erythematous
Clinical narrative: 2 weeks after "SHINGLES SHOT" I developed a red rash on both arms & legs and it burns, feels like shingles without the open sores, 06/05/2015 I still have burning red skin. I've been to 2 Dermatologist for skin patch test & blood food allergy test... nothing found yet.  I need help to conteract this "SHINGLES SHOT VACCINE".
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation, Skin test negative
Clinical narrative: 2 weeks after "SHINGLES SHOT" I developed a red rash on both arms & legs and it burns, feels like shingles without the open sores, 06/05/2015 I still have burning red skin. I've been to 2 Dermatologist for skin patch test & blood food allergy test... nothing found yet.  I need help to conteract this "SHINGLES SHOT VACCINE".
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site induration, Injection site rash, Rash papular
Clinical narrative: Induration and papular rash at site of injection area surrounding no erythema.
Age: 56.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Chills, Fatigue, Injection site pain, Pain
Clinical narrative: Generalized fatigue, body aches, chills and localized tenderness and pain at injection site.
Age: 1.02
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Itchy rash and fever.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Gastrooesophageal reflux disease, Sedation, Somnolence, Vomiting
Clinical narrative: NOT ANAPHYLAXIS. INCREASED SLEEP, SEDATION, DECREASED FEEDING. DID VOMIT BUT HAS REFLUX AS WELL.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Hypersomnia, Pyrexia
Clinical narrative: Low grade fever severe fatigue, slept for 24 hours.
Age: 56.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: REDNESS AND SWELLING PER PATIENT DAY AFTER INJECTION. PT STATES WOULD LIKE TO SEE MD TO BE ON SAFE SIDE.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: PATIENT HAD 5 CM RED AREA WHERE VACCINE ADMINISTERED. ON 6/4 HAD PROGRESSED TO RAISED WHEAL 9-10 CM ACROSS AND RAISED. PATIENT THEN VISITED DOCTOR'S OFFICE.
Age: 71.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre' Syndrome.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Pain
Clinical narrative: Redness and pain. 10 x 5cm induration to left deltoid.
Age: 1.26
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: S/SX: erythema, mild inflammation of (L) thigh (8 x 7 cm) noted one day after injection provided. TX: cool compress, antihistamine, hydrocortisone cream prn.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Mom called on 6/5/15 as patient had syncopal episode at school. Recovered quickly but school staff mentioned syncopal episode could be due to Hepatitis A injection. Advised parents to take her to ED for evaluation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Lacrimation increased, Pain, Rash
Clinical narrative: 1-2 hours after receiving vaccines-c/o body aches, "not feeling well". 5 hours after receiving vaccines-temp 102 degrees F, rash on face, watery eyes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, swelling, warmth and mild induration at injection site began approximately 2 hours after injection placed. Parent gave MOTRIN.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticarial lesions face, extremities, trunk 12-24 hrs. after vaccine administration. No respiratory distress. No dysphagia. No vomiting. No fever. No angioedema. Transient and resolved totally with oral dosing diphenhydramine.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Mom reports MENVEO site is swollen to size of baseball/softball, swelling and increased warm, advised BENADRYL, ice area and to call Monday if area not any better.
Age: 51.0
Sex: M
Vaccine: YF
Symptoms: Injection site rash
Clinical narrative: Got YF shot on the 26th. About pm of 5/30 patient had a rash on YF site. Patient was larger (about 6" width). But didn't hurt. Patient had an ADACEL shot on that arm 5/19.
Age: 50.0
Sex: F
Vaccine: YF
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Got YF shot on the 26th. About PM of 5/30 both patients had a rash on YF site. One patient's was smaller but more sore. Other patient's was larger but did not hurt. Both had an ADACEL shot on that arm 5/29.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Rash, Urticaria
Clinical narrative: Pt called and reported raash all over back, shoulders, neck and went to dr and received rx for ZYRTEC and ZANTAC for hives (not life-threatening).
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site mass, Injection site oedema
Clinical narrative: Edema, erythema and hard lump on right lower upper arm area. Diagnosed with cellulitis right arm, Treated with doxycycline 100mg every 12 hours.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On unknown dates, the unspecified patients were vaccinated with doses of M-M-R II, (strength, dose, frequency, route and anatomical location were not reported), (lot # J016235, expiration date: 19-DEC-2015), which were improperly storage. It was reported that the temperature excursion for M-M-R II was supported with in-house stability data. No adverse symptoms were reported. This is one of two 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 healthcare worker and refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On unknown dates, the unspecified patients were vaccinated with doses of ROTATEQ, (strength, dose, frequency, route and anatomical location were not reported), (lot # J013589, expiration date: 06-JUN-2015), which were improperly stored. It was reported that the temperature excursion for ROTATEQ was supported with in-house stability data. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager via a company representative and refers to a patient of unknown age and gender. Concurrent conditions, medical history and alelrgies were not reported. On 08-MAY-2015, the patient was vaccinated with a dose of PNEUMOVAX23 strength reported as 25/0.5 Y, (dose, freuqency, route, anatomical location, lot number and expiration date were not reported) which had expired. The patient did not experienced any adverse effects. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Small rash on left side of face about 15 not raised and about 5 on right side of face about 6. No itchiness or swelling.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Crohn's disease, Decreased appetite, Inflammation, Pyrexia
Clinical narrative: Not eating, losing weight, severe stomach pain, fever, the inflammation caused Crohn's disease. He has never had any symptoms prior to the vaccine.
Age: 13.0
Sex: M
Vaccine: FLUN4
Symptoms: Weight decreased
Clinical narrative: Not eating, losing weight, severe stomach pain, fever, the inflammation caused Crohn's disease. He has never had any symptoms prior to the vaccine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Pain, Skin warm
Clinical narrative: Warm to touch, painful. 48 hours after injection a 15 cm x 6 cm induration 4cm below the injection site.
Age: 71.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: PT DESCRIBE A RED HARD KNOT AT THE INJECTION SITE AND REDNESS AROUND THE AREA.
Age: 29.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Arthralgia, Psoriasis, Psoriatic arthropathy, Skin plaque
Clinical narrative: Plaque and arthritis psoriasis; joint pain, plaque on body.
Age: 42.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Chills, Decreased appetite, Injection site nodule, Injection site pain, Pain
Clinical narrative: Fever, Chills, soreness/knot at site and body aches, loss of appetite.
Age: 42.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Pyrexia, Systemic inflammatory response syndrome, Vaccination complication
Clinical narrative: Fever, Chills, soreness/knot at site and body aches, loss of appetite.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Bone pain, Cough, Dyspnoea, Headache
Clinical narrative: BP 130/55, P 92bpm, T 101 degrees F, short of breath, coughing, pulsing ache from left side of stomach radiating to left inner thigh, 4"x3.5" elliptical shaped hot, red, swollen patch @ injection site. Head, muscle, bone ache. Incontinence.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Incontinence, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: BP 130/55, P 92bpm, T 101 degrees F, short of breath, coughing, pulsing ache from left side of stomach radiating to left inner thigh, 4"x3.5" elliptical shaped hot, red, swollen patch @ injection site. Head, muscle, bone ache. Incontinence.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: BP 130/55, P 92bpm, T 101 degrees F, short of breath, coughing, pulsing ache from left side of stomach radiating to left inner thigh, 4"x3.5" elliptical shaped hot, red, swollen patch @ injection site. Head, muscle, bone ache. Incontinence.
Age: 1.05
Sex: M
Vaccine: DTAP, MMR, PPV, VARCEL
Symptoms: Pyrexia, Swelling face, Urticaria
Clinical narrative: Hives, fever, swollen face.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial neuralgia
Clinical narrative: The patient was advised to go to ER due to nerve pain in her face. She was prescribed gabapentin and VALTREX.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Injection site pain, Injection site swelling, Metabolic function test
Clinical narrative: Pain/swelling of left deltoid after 3rd Hep B vaccine on 5-20-15. Swelling, dizziness, SOB.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Red blood cell sedimentation rate, Swelling
Clinical narrative: Pain/swelling of left deltoid after 3rd Hep B vaccine on 5-20-15. Swelling, dizziness, SOB.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Pyrexia
Clinical narrative: I administered ZOSTAVAX Sub-Q in left arm on 6/2/15 to the patient. Patient called on 6/3 reporting redness, firmness at injection site and mild fever. I recommended icing site and TYLENOL/ibuprofen for fever and monitor site. She came in on 6/5. Redness had spread, firmness still present, and low grade fever continued. I referred her to Primary Care Physician for evaluation. PCP diagnosed infection at site and ordered course of antibiotics.
Age: 43.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Anuria, Prostatic specific antigen normal, Prostatomegaly, Urine flow decreased, Vaccine positive rechallenge
Clinical narrative: Started experiencing gradual restriction in urinary flow, first noticeable on date above.  Three days later, urinary flow was fully restricted.  Urinary flow did not return to normal until over a month later.  This is the third occurrence that this has happened after being exposed to the flu virus.  In early 2013, it occurred after contracting the flu.  In the Fall of 2013, after receiving the vaccine.  The third episode, also after receiving the vaccine on date above.
Age: 43.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Anuria, Prostatic specific antigen normal, Prostatomegaly, Urine flow decreased
Clinical narrative: Started experiencing gradual restriction in urinary flow, first noticeable on date above.  Three days later, urinary flow was fully restricted.  Urinary flow did not return to normal until over a month later.  This is the third occurrence that this has happened after being exposed to the flu virus.  In early 2013, it occurred after contracting the flu.  In the Fall of 2013, after receiving the vaccine.  The third episode, also after receiving the vaccine on date above.
Age: 43.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Anuria, Prostatomegaly, Urine flow decreased
Clinical narrative: Started experiencing gradual restriction in urinary flow, first noticeable on date above.  Three days later, urinary flow was fully restricted.  Urinary flow did not return to normal until over a month later.  This is the third occurrence that this has happened after being exposed to the flu virus.  In early 2013, it occurred after contracting the flu.  In the Fall of 2013, after receiving the vaccine.  The third episode, also after receiving the vaccine on date above.
Age: 43.0
Sex: M
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Anuria, Urine flow decreased
Clinical narrative: Started experiencing gradual restriction in urinary flow, first noticeable on date above.  Three days later, urinary flow was fully restricted.  Urinary flow did not return to normal until over a month later.  This is the third occurrence that this has happened after being exposed to the flu virus.  In early 2013, it occurred after contracting the flu.  In the Fall of 2013, after receiving the vaccine.  The third episode, also after receiving the vaccine on date above.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: High fever 101.9.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Back pain, Mobility decreased, Pain
Clinical narrative: Could not get out of bed, severe back pain, abdominal pain, whole body hurt.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Emotional distress, Listless, Screaming, Somnolence, Staring
Clinical narrative: Groggy, listless, aimless stare, woke screaming and unconsolable (very high pitched); cried intermittently for no reason (again unconsolable).
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Blood test, Electroencephalogram, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Seizures.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Electroencephalogram, Eye movement disorder, Nuclear magnetic resonance imaging, Tremor
Clinical narrative: Seizures.