chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown patients of unknown age and gender. Current conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of PROQUAD (Lot # M018638, expiration date 11-OCT2-017; M021731, expiration date 17-OCT-2017; M015695 26-SEP-2017) (Dose and route were not provided). Concomitant medications were not reported. The temperature excursion details were -11.2C for 1 hour 18 minutes. A second freezer containing different lots for Lots M011663, expiration date 08-SEP-2017; M015698, 26-SEP-2017; M029595, 31-DEC-2017, with a temperature excursion of -12.9C for 48 minutes. The lot# M015695, expiration date 26-SEP-2017) had an additional excursion of -9 C for 2 hours. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via a company representative referring to a female patient, who was currently in eighth grade. The patient had no remarkable medical history and she was not in stressed fashion. The patient's concurrent condition and concomitant therapy were unknown. On an unknown date (reported as "when she was a young child"), the patient was vaccinated with one dose only of VARIVAX (dose, route, lot # and expiration date not reported). On an unknown date of August 2016 (reported as "the last month"), the patient experienced shingles. The patient sought medical attention via visiting the physician. The shingles subsided on an unknown date in 2016 and the patient was okay at the time of this report. The causality between VARIVAX and the event was not provided. 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 pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the improperly stored dose ZOSTAVAX (lot # M019646, expiration date 18-JUL-2017, subcutaneously; dose was not reported). No adverse effects were reported. The vaccine was stored in 10F for 48 hours and on the another date, in 10F for 24 hours. The call was made because of the data logger. This is one of several reports 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 medical assistant regarding unknown patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On an unknown dates, the unknown patients were vaccinated with improperly stored doses of ROTATEQ (lot # M004883 and expiry date 31-OCT-2017) (dose, frequency and route were unknown). No concomitant medications were reported. On unspecified dates the vaccine was exposed to temperature excursions of 1 Celsius for 176 hours and 9 Celsius for 32 hours. There were no prior excursions and a data logger was not used. No adverse effects were reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unknown patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On an unknown dates, the unknown patients were vaccinated with improperly stored doses of M-M-R II (lot # L037356 and expiry date 30-SEP-2017) (dose, frequency and route were unknown). No concomitant medications were reported. On unspecified dates the vaccine was exposed to temperature excursions of 1 celsius for 176 hours and 9 celsius for 32 hours. There were no prior excursions and a data logger was not used. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 23-SEP-2016, the patient was inadvertently vaccinated with expired M-M-R II lot # K014833, expiry date: 14-SEP-2016 (dosing details was not reported). No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse, who was also the patient's sister and refers to a female patient of an unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were unknown. On 16-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously in "the underside of her arm instead of the deltoid" (dose, lot number and expiration date were not reported). The vaccine was administered by a pharmacist. On an unknown date in September 2016 (reported as after an unspecified amount of time), the patient experienced swelling and redness at the injection site resolved. The patient did not seek medical attention. It was unknown if any lab diagnostic studies were performed. No treatment was given for the events. The reporter stated that symptoms "lasted for an unspecified duration of time" but did not specify if swelling and redness at the injection site resolved. The call was disconnected before further information could be obtained. The outcome of the events was considered unknown. The relatedness between swelling and redness at the injection site and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: ANTH, FLU4, PPV, TYP
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: Swelling on the inoculated right arm. Swollen lymph nodes.
Age: 40.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Feeling cold, Injection site pain, Pyrexia
Clinical narrative: Extremely high fever and chills (peaked at 104.2). Severe arm pain in injection-site arm.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Rash pruritic, Vomiting
Clinical narrative: Itchy rash presented itself on torso, back, arms, and legs accompanied by dizziness, nausea, and vomiting. After vomiting, dizziness subsided and rash resolved within a few hours.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm that has persisted for 3 to 4 weeks since vaccination.  Patient went to see MD and MD says that the soreness was due to the vaccination.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Pain in extremity
Clinical narrative: Pain on the opposite side of the arm. General Malaise.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Swollen tongue, Throat irritation
Clinical narrative: Itchy throat and minor swelling of tongue. This occurred 10 minutes after given the vaccination. His symptoms lasted for ten minutes and then went away. Epi pen was not given as patient did not admit to tongue swelling until after symptoms were gone.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling cold, Influenza like illness, Influenza virus test negative, Night sweats, Pain
Clinical narrative: Flu-like symptoms, low-grade fever, body aches, chills, night sweats.  Symptoms only occurred at night.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: Flu-like symptoms, low-grade fever, body aches, chills, night sweats.  Symptoms only occurred at night.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient noticed pain in shoulder area around midnight 9/27/16.  The pain has spread from neck down to fingertips around 3 AM disturbed her sleep.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site bruising, Injection site erythema
Clinical narrative: Patient stated that initally there was a red line horizontally underneath the injection and then the next day the patient noticed bruising at the site of injection approximately the size of a half dollar.  Bruise has lasted for a week and patient also stated that there was "numbness down to the bone".
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report was received from an approximately 71 year old female patient, regarding herself. The patient's pertinent medical history and drug reactions/allergies were reported as none. Concomitant therapies included levothyroxine sodium(manufacturer unknown). In 2015 (about a year ago), the patient was vaccinated with ZOSTAVAX, 1 dose, (therapy route and lot#/expiry date were unknown). The patient reported that about a day after receiving ZOSTAVAX, she developed a hard lump, as big as an egg, on the under side of the right arm where she received the vaccine. Shortly after developing the lump, she also had muscle pain, like a stinging sensation, at the injection site. The patient stated that it was not painful however it was distracting. No treatment was given for the adverse events. Routine unspecific blood work up was performed. About 6 months ago the lump, decreased and was no longer there (recovered), however the muscle pain was still there (not recovered). Causality assessment was not provided. Patient sought medical attention (spoke with pharmacist). No product quality complaint (PQC) was involved. No Further adverse event information was provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Pt received GARDASIL and right after pt had a slight episode of near syncope for approx. 30 secs. Pt was layed down cool compress applied to head. BP checked and wnl. Pt was then examined by Dr. Pt was given crackers and water. Pt was observed for 30 mins then released.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Myalgia, Rash
Clinical narrative: Day after vaccine was administered, patient had a rash on upper arm down to elbow. Two days after, she presented with muscle/joint aches and diarrhea.
Sex: M
Vaccine: IPV, PNC13
Symptoms: Cellulitis, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. The nurse reported similar events for 2 patients. This is the 1st of 2 reports. A patient of an unspecified age, gender and ethnicity received PREVNAR 13 (Lot. M35760, expiration date 01May2017) IM at 0.5 ml single dose at anterior aspect left thigh at 4:15 PM, and polio vaccine (IPV, Sanofi; Lot#: M1453) IM at right thigh, both on an unknown date for immunization. Relevant medical history and concomitant medications were unknown. The patient previously received 3 doses of polio vaccine (IPV, Sanofi; Lot#: M1453) IM at right thigh. On 15Aug2016, the patient experienced reactions such as swelling and welting at the injection site. The patient's arm looked like it was turning into cellulitis. No specific tests and/or treatment was required. The AEs did not require an emergency room or physician visit. Clinical outcome of the events was recovered at time of this report. The reporter stated that the patient did provide to him/her information regarding the reported adverse events with the use of the suspect. The nurse stated there was a reasonable possibility that the event is related to suspect product. The reporter was willing to be contacted again by Pfizer on the reported adverse events. Follow-up (14Sep2016): New information reported from a contactable nurse included: PREVNAR 13 route,  expiration date, dosage, anatomical location, vaccination time; event onset date and outcome; co-suspect polio vaccine added, reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016390391 Same reporter/drug, different patient/AE.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This is a spontaneous report from a contactable Pharmacist reporting on behalf of a patient. An over 65 year female patient of an unspecified ethnicity received PREVNAR 13, L(ot # M13068, Expiry Date Apr2017, NDC #  0005197102) via an unspecified route of administration at single dose on 08Sep2016 for immunisation. The patient medical history was not reported. Concomitant medications included flu vaccine on 08Sep2016 for immunization. On 10Sep2016 the injection site started itching and turned red. She put cold rags on it and took BENADRYL which didn't do anything. She has been using Benadryl for several days.  Reporter has not seen a reaction like this before. She had no fever, and did not feel bad. The area was not swollen, just red and itches and burns. It was the size of a small orange and started at the top of her arm down to a little below the injection site. The events outcome was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program: IBCC (Inbound Call Center for HCPs).  A contactable pharmacist reported that a 65 years old female patient received PREVNAR 13 (lot N05077, expiry date Sep2017, NDC number 00005197106, UPC number 00051971022) intramuscular, in arm, on 14Sep2016, at 0.5 ml, single, for immunisation.  The patient medical history was none. The patient's concomitant medications were not reported.  The patient experienced red, slightly swollen very warm arm and it had itches on 21Sep2016 with outcome of not recovered. The patient came back into the pharmacy with red and swollen arm and she wanted to know if that was normal. The pharmacist recommended the patient some treatment but she was not sure if the she had used it or not. No emergency room or doctor visit were required. The reporter considered the events were related to the administered vaccine.
Age: 59.0
Sex: M
Vaccine: MEN
Symptoms: Dyspnoea, Nausea, Paraesthesia, Sleep disorder
Clinical narrative: Initial unsolicited report received from a healthcare professional (intern pharmacist) on 16-Sep-2016 and a live follow up also received on 20-Sep-2016. This case involves a 59-year-old male patient who was vaccinated with a dose of MENOMUNE (batch number: UI041AA, expiry date: 10-SEP-2017) (dose, dose in series, route and site of administration were not reported), on 18-AUG-2016. It was reported that the patient also received a diluent (batch number: U1566AB, expiry date: 12-APR-2018) on the same day. Patient's Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergic to clindamycin, penicillin, Sulfa drugs and medical history includes Asthma, Herpes Simplex Virus, Herpes Zoster (had shingles) HIV infection. Concomitant medications were not reported. On an unspecified date (7-8 days "also reported 7 days" after), following the vaccination, the patient had difficulty breathing to the point had trouble sleeping, nausea and tingling down of arms and legs. Lab data and corrective treatment were not reported. On an unspecified date (5 days after the date they had started), the patient recovered from all the events. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Injection site erythema, Pain, Pruritus
Clinical narrative: Received vaccines on 9/16/16, since vaccines were given had erythematous patch to (R) anterior thigh, afebrile. Intermittent c/o pain and itchiness. No previous reaction to vaccine, no allergies. 6 cm x 6.5 cm, center of patch with 1 cm area with some induration, no drainage.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain, Fatigue, Hypoaesthesia, Hyporeflexia, Laboratory test
Clinical narrative: Presented to ER with abdominal pain, testicular pain, urinary retention, fatigue, decreased reflexes lower extremities and numbness of extremities.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Testicular pain, Urinary retention
Clinical narrative: Presented to ER with abdominal pain, testicular pain, urinary retention, fatigue, decreased reflexes lower extremities and numbness of extremities.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Pt. received PPV-23 on  8/29/16. On 8/30/16, pt. reported redness and swelling, was given KEFLEX. On 8/31 pt. presented to ER and was admitted. Pt. hospitalized until 9/3/16 for cellulitis.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Dizziness
Clinical narrative: PATIENT STARTED TO FEEL DIZZY. I TRIED TO GIVE HER FLUIDS AND SOME SOURCE OF CARBS BUT SHE STILL FELT DIZZY. SO I TOOK HER TO THE URGENT CARE NEAR BY.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Rash covering entire body.  It was very itchy initially. Patient self treated with cortisone cream. 1 week later, rash persists but fading, but no longer itchy.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Flushing, Headache, Hot flush, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Immediate pain in entire arm, numbing of fingers, headache, flush cheeks and hot flashes. Fever set in later in the afternoon. 24 hours later body aches, headache, Fever of 102°
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Immediate pain in entire arm, numbing of fingers, headache, flush cheeks and hot flashes. Fever set in later in the afternoon. 24 hours later body aches, headache, Fever of 102°
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Blood pressure decreased, Hypotonia, Loss of consciousness
Clinical narrative: Child became limp and lost consciousness.  Child laid on table with feet elevated.  Did respond to name, but quickly lost consciousness again.  Child self-revived.  Blood Pressure was decreased but increased as he became more conscious.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from an unspecified reporter via company representative and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9, intramuscularly (strength, dose, lot# and expiration date were not reported). On an unknown date, after being administered with GARDASIL 9, the patient "fainted" and was rushed to the hospital. The outcome of the event was unknown. The relatedness between the event and GARDASIL 9 vaccination  was not reported. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Blindness, Body temperature increased, Chills, Oropharyngeal pain
Clinical narrative: W/i 1hr of getting flu shot (got at pediatrician's), got Tm 103, chills, body aches, sore throat; next am woke up with temp and fainted; after episode of intense abd pain, vision went out, then was dreaming and woke up; not sure if how long episode lasted; taking Advil; feeling h/a and slight LH.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Syncope
Clinical narrative: W/i 1hr of getting flu shot (got at pediatrician's), got Tm 103, chills, body aches, sore throat; next am woke up with temp and fainted; after episode of intense abd pain, vision went out, then was dreaming and woke up; not sure if how long episode lasted; taking Advil; feeling h/a and slight LH.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Adenovirus test, Ataxia, Bacterial test negative, Benzodiazepine drug level, Blood immunoglobulin M normal
Clinical narrative: Headache, fever, vomiting, and severe ataxia. Hospitalized for 28 days and given supportive care. CSF had elevated WBC's but was negative for enterovirus and HSV. Also bacterial cultures were negative. Enterovirus only isolated from respiratory panel. At time of discharge patient had returned to baseline. Unsure if will have complete resolution of symptoms.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Bordetella test negative, CSF cell count increased, CSF glucose normal, CSF lymphocyte count normal, CSF monocyte count decreased
Clinical narrative: Headache, fever, vomiting, and severe ataxia. Hospitalized for 28 days and given supportive care. CSF had elevated WBC's but was negative for enterovirus and HSV. Also bacterial cultures were negative. Enterovirus only isolated from respiratory panel. At time of discharge patient had returned to baseline. Unsure if will have complete resolution of symptoms.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: CSF protein normal, CSF red blood cell count positive, CSF white blood cell count increased, Creatinine urine normal, Drug screen negative
Clinical narrative: Headache, fever, vomiting, and severe ataxia. Hospitalized for 28 days and given supportive care. CSF had elevated WBC's but was negative for enterovirus and HSV. Also bacterial cultures were negative. Enterovirus only isolated from respiratory panel. At time of discharge patient had returned to baseline. Unsure if will have complete resolution of symptoms.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Enterovirus test negative, Eosinophil percentage, Headache, Herpes simplex test negative, Human metapneumovirus test
Clinical narrative: Headache, fever, vomiting, and severe ataxia. Hospitalized for 28 days and given supportive care. CSF had elevated WBC's but was negative for enterovirus and HSV. Also bacterial cultures were negative. Enterovirus only isolated from respiratory panel. At time of discharge patient had returned to baseline. Unsure if will have complete resolution of symptoms.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Human rhinovirus test, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Laboratory test normal
Clinical narrative: Headache, fever, vomiting, and severe ataxia. Hospitalized for 28 days and given supportive care. CSF had elevated WBC's but was negative for enterovirus and HSV. Also bacterial cultures were negative. Enterovirus only isolated from respiratory panel. At time of discharge patient had returned to baseline. Unsure if will have complete resolution of symptoms.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Monocyte percentage, Opiates negative, Platelet morphology normal, Polymerase chain reaction, Pyrexia
Clinical narrative: Headache, fever, vomiting, and severe ataxia. Hospitalized for 28 days and given supportive care. CSF had elevated WBC's but was negative for enterovirus and HSV. Also bacterial cultures were negative. Enterovirus only isolated from respiratory panel. At time of discharge patient had returned to baseline. Unsure if will have complete resolution of symptoms.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Respiratory syncytial virus test negative, Specific gravity urine decreased, Streptococcus test negative, Urine amphetamine negative, Urine protein, quantitative
Clinical narrative: Headache, fever, vomiting, and severe ataxia. Hospitalized for 28 days and given supportive care. CSF had elevated WBC's but was negative for enterovirus and HSV. Also bacterial cultures were negative. Enterovirus only isolated from respiratory panel. At time of discharge patient had returned to baseline. Unsure if will have complete resolution of symptoms.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Varicella virus test negative, Viral test negative, Vomiting, pH urine normal
Clinical narrative: Headache, fever, vomiting, and severe ataxia. Hospitalized for 28 days and given supportive care. CSF had elevated WBC's but was negative for enterovirus and HSV. Also bacterial cultures were negative. Enterovirus only isolated from respiratory panel. At time of discharge patient had returned to baseline. Unsure if will have complete resolution of symptoms.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Vaccination site haematoma
Clinical narrative: She developed redness in the area of the vaccine that extended into a large area on the right upper arm. She was seen at the pharmacy and advised to do warm compress to the area. There has been dramatic improvement. She still has area of redness directly around the site of the vaccination. She has a hematoma in the location of the influenza vaccination on the right arm.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Induration, Mass, Rash, Skin warm
Clinical narrative: She developed redness in the area of the vaccine that extended into a large area on the right upper arm. She was seen at the pharmacy and advised to do warm compress to the area. There has been dramatic improvement. She still has area of redness directly around the site of the vaccination. She has a hematoma in the location of the influenza vaccination on the right arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Vaccine given 9-25 in the evening. Reaction on arm noticed 9-26 morning. About a 3 in circle pink reaction - warm to touch.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to an elderly female patient of unknown age with hypertension. The patient's medical history was not reported. On 20-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, administered in an unspecified arm (dose, dose number, route, frequency, lot number and expiration date were not provided). Concomitant medication information was not provided. On 20-SEP-2016, the patient's arm became "red and hot" and it was diagnosed with cellulitis. As a result, the patient sought medical attention and cephalexin was prescribed as treatment with an unknown dose, 4 times daily for 4 weeks. However, the patient was not hospitalized, there was no significant disability or incapacity, the event was not a congenital anomaly, there was no life threatening situation and the patient did not die. No product quality complaint (PQC) was involved. At the time of reporting, the outcome of cellulitis was reported as not recovered. The primary reporter did not provide the causal relationship between PNEUMOVAX 23 and cellulitis. Upon internal review, cellulitis was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M025565, expiry date: 06-NOV-2017) orally. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Pain, Pain in extremity, Sleep disorder
Clinical narrative: A few hours after pneumonia booster was given his arm became painful to move and continued to worsen. He couldn't sleep that night and had to skip bowling the next day because he couldn't lift his arm. There was no redness or swelling - just pain. He was better the third day after the injection.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: the patient stated when they took the bandage off 9/26 am they had a mark and red area (approximately 3" size) where the vaccine was given. She went to the doctor and was told it was irritation due to the vaccine solution but they expect it to heal on its arm and didn't prescribe any treatment.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. It was reported that on 17-JUN-2016 and 22-JUL-2016, an unspecified number of doses of M-M-R II lot # L036853 with expiration date of 24-SEP-2017 were exposed to a temperature excursion potential of 72 degrees F and 87.5 degrees F, respectively. Some doses of this lot were administered to the patients on 17-JUL-2016 (the route was not provided). Additionally, other doses of lot # L005291 with expiration date of 17-FEB-2017 were also exposed to the mentioned temperature excursion on the same dates and the doses were administered on 18-JUL-2016 and 26-JUL-2016. At the time of the report, the patients' status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Gianotti-Crosti syndrome, Rash papular
Clinical narrative: Gianotti-Crosti type papular rash 2-4 weeks after vaccine. Rash lasted greater than 6 weeks.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot number L048464, expiration date: 08-AUG-2016 and lot number M003439, expiration date: 19-JAN-2018, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the VARIVAX with lot number L048464 and expiration date: 08-AUG-2016 underwent a temperature excursion of -11 degrees Celsius for an unknown amount of time that was less than 352 hours and 51 minutes, while the vaccine with lot number M003439 and expiration date: 19-JAN-2018 underwent a temperature excursion of -11 Celsius for 352 hours and 51 minutes. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. The primary reporter did not report any doses of VARIVAX lot L048464, expiration date: 08-AUG-2016 that were given after the expiration date. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter (linked with MARRS# 1609USA012656). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to about 9 patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown date, about 9 patients were vaccinated with improperly stored ROTATEQ (lot # L044476, expiration date 07-SEP-2017; dose was unknown) orally. The vaccines were expose to 54.7 Fahrenheit degree for 39 hours, 27.7 Fahrenheit for 1 hours and 56 Fahrenheit degree for 3 hours and 3 minutes. No adverse effect reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Pt had severe soreness at injection site immediately. It was still hurting 1 week later. No redness or mark.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving vaccine no treatment needed at that time, rest, cup of water, snack.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Rash, Rash papular
Clinical narrative: Rash 2-4 weeks after vaccine. Rash papular on trunk and extremities.
Age: 68.0
Sex: M
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Pain, Pruritus, Swelling
Clinical narrative: Pruritis followed by swelling and pain resulting in limited ROM. Conservative management with heat/cold packs and NSAIDS PRN.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (dosing details were not reported (lot # M018810, expiry date: 28-MAY-2018 (incorrect product storage). No adverse effect were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: HEP
Symptoms: Flushing, Throat tightness
Clinical narrative: Facial flushing, throat tightness for 10 minutes; administered BENADRYL 50 mg with good effect.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Disturbance in attention, Fatigue, Nausea
Clinical narrative: Day after immunization, patient felt nauseated, tired, could not focus. Had to leave work the next day. Following day felt fatigued.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Small raised bump on skin at injection site. Approximately 2 weeks after injection (8/31), it was noticed.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: A few hours after pneumonia vaccine was given my arm was swollen from the shoulder to elbow and bright red - very tender to touch and hot to touch. It was hard to lift arm without pain. It was a booster vaccine - we received the regular vaccine 2 yrs earlier. The symptoms started fading after 4 days and were gone on the 7th day. We did not seek treatment but reported event to VAERS and SAFEWAY- After over.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Erythema, Headache, Paraesthesia
Clinical narrative: Arm tingling, redness, headache and blisters on feet and legs.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Pruritus
Clinical narrative: Local itching after administration of vaccine with minutes (1-5  minutes). Itching resolved quickly 5-10 minutes. Flu like symptoms 1-2 days after vaccine administrations.
Age: 97.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Patient complained of redness, inflammation and warmth at site of injection 6 days after immunization. RPH advised to apply ice pack. RPH advised pt. to monitor and come back if reaction worsens. Pt. came back next date b/c symptoms worsened and saw doctor. Dr said it was an infection and prescribed KELFEX.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Bone pain, Cranial nerve disorder, Eyelid ptosis, Facial paralysis
Clinical narrative: Drooping lip and eyelid on one side of face. Cranial Pain.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Febrile convulsion, Irritability, Tension, Tremor
Clinical narrative: On 4/28/16 patient had temp 99 degrees and was fussy-became tense and began shaking. Lasted approximately 15 min per Dad. No color change or difficulty breathing. Seen at an urgent care. No labs obtained. Felt to be likely febrile seizure.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain, Pruritus, Pyrexia
Clinical narrative: Fever, red area, pain, itch. Cefadroxil 500 mg one BID, Acetaminophen 500mg one every 4 hours csn, Hydroxyzine Hcl 25mg one every 6 hours.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Dyspnoea, Herpes simplex, Respiratory symptom, Wheezing
Clinical narrative: Wheezing, acute asthmas attacks, flare up of Herpes Simplex, shortness of breath, upper respiratory symptoms.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Chills, Gastrointestinal disorder, Myalgia, Pyrexia
Clinical narrative: Muscle aches, chills, fever, tremors, digestive problems, weight loss.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Tremor, Weight decreased
Clinical narrative: Muscle aches, chills, fever, tremors, digestive problems, weight loss.
Sex: F
Vaccine: FLU4
Symptoms: Autopsy, Death
Clinical narrative: This case was reported by a consumer and described the occurrence of unknown cause of death in a 70-year-old female patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The patient was the relative of the reporter. The patient received the vaccine and died on an unknown date due to an unknown cause. The autopsy details were not provided. Due to the patient's death after taking the FLULAVAL vaccine, the reporter was afraid to get the vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Rash
Clinical narrative: This spontaneous report was received from a 61 year old male patient, via a company representative, reporting on himself. Pertinent medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneously. Dose, lot # and expiration date were not reported. It was stated that after receiving ZOSTAVAX the patient developed a headache that lasted 3 days and developed a rash on his back. It was not a product quality complaint involved. At the time of reporting the outcome of Rash was unknown. The causality assessment between the events and the suspect therapy was not reported. Additional information is not expected as not contact details were provided.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Could not lift arm w/0 pain (same arm in which shot was administered). NO: warmth, red, swelling or sx consistent with infection. Treatment w/Naproxen not helpful.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Mass
Clinical narrative: Quarter sized lump spread the diameter of 3 quarters together, red. Tx: TYLENOL, ice/cool compress.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Formication, Peripheral swelling, Pruritus, Rash
Clinical narrative: Red raised hives arms, abdomen, legs, itchy hands with rash, No SOB - Rx: OTC BENADRYL. 9/22/16- 36 hour later, awoke with hives, swelling - to ER. IV SOLU MEDROL with Scrip for Po. FYI  Pt walked thru wood before injection. 9/22 12pm Woke the AM with hives face, hand swelling, feeling of "fire ants crawling on him" and short of breath. Went to hospital as directed - tx with IV steroids. Per patient - ER doctor said, this reaction to vaccine rare but pt. states only potential allergen. Advised to f/u with Dr and now to list vaccine as his allergy.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Red raised hives arms, abdomen, legs, itchy hands with rash, No SOB - Rx: OTC BENADRYL. 9/22/16- 36 hour later, awoke with hives, swelling - to ER. IV SOLU MEDROL with Scrip for Po. FYI  Pt walked thru wood before injection. 9/22 12pm Woke the AM with hives face, hand swelling, feeling of "fire ants crawling on him" and short of breath. Went to hospital as directed - tx with IV steroids. Per patient - ER doctor said, this reaction to vaccine rare but pt. states only potential allergen. Advised to f/u with Dr and now to list vaccine as his allergy.
Age: 30.0
Sex: F
Vaccine: FLU4, HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Pruritus, Rash
Clinical narrative: Redness, itching, and rash started on upper left arm, shoulder and onto chest and back - approx 8 inches on 9/20/16 at 3:00pm. Lasted until 9/22/16 AM. Almost completely gone at 9/22/16 - 8:45AM.
Age: 30.0
Sex: F
Vaccine: FLU4, HEP, MMR, VARCEL
Symptoms: Skin reaction
Clinical narrative: Redness, itching, and rash started on upper left arm, shoulder and onto chest and back - approx 8 inches on 9/20/16 at 3:00pm. Lasted until 9/22/16 AM. Almost completely gone at 9/22/16 - 8:45AM.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary mass, Injection site erythema, Local swelling, Oedema peripheral
Clinical narrative: Vaccine given IM in left deltoid on 9/20/16. On 9/21/16 developed swelling in left axilla and baseball sized redness to injection site. On morning of 9/23/16, swelling developed in base of neck on left side. 50 cent sized lump in left axilla. No c/o pain. Previous reaction of swelling after flu vaccine in 2014.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: LUE, redness over lateral aspect, some swelling, tenderness.
Age: 5.0
Sex: F
Vaccine: HEP, HEPA, MMRV
Symptoms: Injection site rash, Injection site scab, Injection site swelling
Clinical narrative: Pt developed circular raised rash at site 20x34mm at time pt visit with scab in center.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to multiple patients of unknown age. The patient's medical history and concurrent conditions were not provided. On multiple unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M004883, expiration date: 02-OCT-2017, orally (concentration, dose, frequency were unknown). Information regarding concomitant medication was not reported. Additionally, it was also reported a temperature excursion of 33.2 degrees Fahrenheit for 30 minutes due to a data logger. No adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster, Pain, Rash generalised
Clinical narrative: This spontaneous report was received from a consumer a 75 year old female patient about herself. Concomitant medication and medical history was not reported. On 06-NOV-2008 the patient was vaccinated with both ZOSTAVAX and PNEUMOVAX 23 at the same time. Patient experienced shingles on 08-FEB-2016, and again on 18-AUG-2016. The patient stated that she was treated by her physician both times with unspecified medication. The patient stated that the second episode of shingles was much worse than the previous episode as it was more painful and described shingles rash was throughout her body. The outcome of second episode of shingles was reported as not recovered as it had not cleared up yet. The causality of shingles was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of localized erythema in a 61-year-old female patient who received FLULAVAL Quadrivalent (batch number 5S349, expiry date 31st May 2017). On an unknown date, the patient received FLULAVAL Quadrivalent .5 ml. On an unknown date, an unknown time after receiving FLULAVAL Quadrivalent, the patient experienced localized erythema and local swelling. On an unknown date, the outcome of the localized erythema and local swelling were unknown. It was unknown if the reporter considered the localized erythema and local swelling to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness and swelling in the deltoid area of her left arm after vaccination with FLULAVAL Quadrivalent.
Sex: U
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of swelling in a patient who received FLULAVAL Quadrivalent. On 15th September 2016, the patient received FLULAVAL Quadrivalent. On 15th September 2016, less than a day after receiving FLULAVAL Quadrivalent, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown. It was unknown if the reporter considered the swelling to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced significant swelling after vaccination with FLULAVAL. This report came in through a live chat and the reporter decided to call into medical information to provide the details related to this. The reporter did not collect any additional information via chat like lot number, expiry date, patient initials, date of birth or gender.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling cold, Hyperhidrosis, Nervousness, Pain
Clinical narrative: Patient complained of feeling shaky, cold, aches and pains, sweating, missed one day of work completely, taking TYLENOL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Peripheral swelling, Pyrexia, Rash erythematous
Clinical narrative: Mother called on 9/8/16 reporting left arm "swollen, fever in it, and red bumps". "Bumps just started popping up today-describes as red-not like blisters. Indicated upper muscle site of deltoid injection-not the SQ injection which was placed lower. 9/13/16 Took to NP on 9/8/16. Told mom it was a common reaction and if gets worse to take to ER. Was also given BENADRYL to prevent itching. Did not get any worse and is feeling ok know-only small amt redness, swelling and very few bumps at site.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Large, red, swollen, inflamed area around injection site approximately 4" x 2"
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Liver injury, Renal injury
Clinical narrative: Pt said he started having stomach pain on 9/25/16 (10 days after flu shot) Went to Hospital on 9/26/16 and claimed they refused to see him. He stated he has Kidney and Liver damage from the flu shot. I asked for test results and records but pt has nothing to give me.
Age: 72.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site mass, Injection site reaction, Insomnia, Somnolence
Clinical narrative: Chills without fever, drowsiness but unable to sleep, and a lump at the injection site.
Age: 41.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Drug administered at inappropriate site, Emotional distress
Clinical narrative: Emotional distress due to higher site of administration.
Age: 41.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Drug administered at inappropriate site, Injection site haemorrhage
Clinical narrative: Emotional distress due to higher site of administration.
Age: 41.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Drug administered at inappropriate site, Emotional distress
Clinical narrative: The company hold a Wellness Fair for employees providing biometric screening and flu shot. The administering immunizer as indicated who is from pharmacy gave me a flu shot in the wrong spot on my right arm. The needle poked several times and they are way too high - on the top of my shoulders, the vaccine was injected into my shoulder joint and caused severely bleeding.