chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurses via a company representative referring to multiple unknown patients of unknown age and gender. Information regarding drug reactions/allergies, pertinent medical history and concomitant medication was not reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # M007277 with expiration date 09-FEB-2018; dose, and route were not reported) for prophylaxis (incorrect product storage). There were previous temperature excursion and multiple temperature excursion and time frame (details were unable to provide). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003022.
Sex: U
Vaccine: FLUN4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On 09-NOV-2015, the patient was vaccinated with PROQUAD (lot # L027634 with expiration date 21-JAN-2017, dose and route were not reported) for prophylaxis. On 14-NOV-2015, the patient received FLUMIST, which is sooner than the recommended 28 day waiting period for the concomitant administration of live vaccines, if not given simultaneously (product use issue). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been as received from a nurse concerning a patient of unknown age and gender. Information about the patient's concurrent condition, concomitant medication and medical history was not provided. On an unknown date that was after 22-AUG-2013, the patient was vaccinated with PNEUMOVAX 23 (lot# 0492AE, expiration date 22-AUG-2013) (strength, dose, frequency and route were not reported) for prophylaxis (expired product administered). No adverse effects were reported. Additional information is not expected because no consent was given for the follow-up.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning multiple patients of unknown ages and gender. The patients' pertinent medical history, drug reactions, allergies and concurrent conditions were not informed. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lots #, expiration dates, dosages and therapy routes were not provided), for prophylaxis. Concomitant therapies were not informed. The pharmacist was not aware of any adverse effect. The doses of PNEUMOVAX 23 were exposed to a temperature of 33F and were out of range for 10 days. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 61-year-old female patient. The patient had no drug allergies. Her pertinent medical history and concomitant medication were not reported. On 28-NOV-2016, the patient was vaccinated with ZOSTAVAX lot # M001747 with expiration date of 07-APR-2017, subcutaneously (strength and dose were not reported). On an unspecified date in November 2016, the patient experienced a 5 centimeter area of erythema and a 13 centimeter raised area around the injection site. The patient was seen by an unspecified physician on 30-NOV-2016. There was no lab diagnostic study performed. At the time of reporting, the patient was not recovered from the events. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On 01-DEC-2016, the patient was vaccinated with improperly stored ZOSTAVAX (dose: 0.65 ml, once, lot # M033910, expiry date: 17-OCT-2017) via subcutaneous route, for prophylaxis. Pharmacist reported that at the time of the vaccine administration, she was unaware of the excursion until 1 hour later. She mentioned that the vaccine was exposed at less than 0C but not more than 0C, for 4 hours. There were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent medical conditions, concomitant therapies, and medical history were not provided. The patient was administered dose one of PEDVAXHIB (dose, strength, frequency, route, lot# and expiration date were unknown) in April 2016 and dose two in July 2016 for prophylaxis, which was one month after recommended date (drug use for unapproved schedule). No adverse effects reported. Addition information is not expected because there is no consent to contact the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurses via a company representative referring to multiple unknown patients of unknown age and gender.  Information regarding drug reactions/allergies, pertinent medical history and concomitant medication was not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M027343 with expiration date 01-JUN-2018; dose, and route were not reported) for prophylaxis (incorrect product storage).  There were previous temperature excursion and multiple temperature excursion and time frame (details were unable to provide). No adverse effects were reported. This is one of several reports from the same reporter.  Additional information has been requested.  Sender's Comments:  US-009507513-1611USA011369.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 28-Nov-2016. This case involves a 68-year old female patient who was vaccinated with FLUZONE HD via intramuscular route (Batch number: UI691AA, expiry date: 30-Apr-2016; dose and dose in series were not reported) in left deltoid on 28-Sep-2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as no known allergies. It was also reported that patient had no illness at the time of vaccination. Concomitant medications was not reported. On 27-Nov-2016, 10-week after the vaccination, patient experienced sore left arm and was also unable to raise arm and symptoms just began. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Initial unsolicited report received from a consumer on 26-NOV-2016. This case involves a six-year-old male patient who was vaccinated with a dose of FLU VACCINE (batch number, expiry date, dose, dose in series, route of administration were not reported) in left arm (just below the shoulder in the back), on 23-November of an unspecified year (reported as on Friday, Nov 23rd). Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient has significant swelling and pain from the injection site to the top of his elbow. Lab data was not reported and corrective treatment was reported as motrin and ice packs on the site. The outcome of the event was not reported. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Dizziness, Headache, Paranasal sinus discomfort
Clinical narrative: Resident received flu vaccine left deltoid 12/5/16 at 8am. He also received BEXSERO (#1) Rt deltoid 12/5/16 at 8:10AM. On 12/6/16 at app 8am, developed severe H/A sinus pressure in maxillary region, dizziness. Vital signs normal baseline.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Injection site urticaria, Pain, Skin warm
Clinical narrative: Area is extremely hot to the touch, Hives below the site, bruising, pain with movement at shoulder.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Heart rate increased, Palpitations, Paraesthesia
Clinical narrative: Around 2 PM today she developed tingling in her right fifth finger while driving. She states approximately 15 minutes earlier she had gotten a tetanus shot. She states that the tingling had persistent throughout the evening but she went to work and noted the tingling only when she tried to start an IV. At approximately 8 PM she developed sudden onset sensation that her heart was beating faster and developed tingling on the palms of her hands and feet bilaterally. The palpitations resolved but she still has tingling sensation on her hands and feet. She denies any other symptoms. She specifically denies any rash, throat swelling, difficulty breathing, dizziness, syncope, chest pain, or shortness of breath. She also denies any headache, confusion, speech or vision changes, weakness, loss of balance, or any other paresthesias other than in her hands and feet.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Patient got 3 cold sores and has never had one.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Headache, Influenza like illness, Musculoskeletal stiffness, Neck pain
Clinical narrative: Headache, stiff neck, fatigue, lasting for over a week so far. Wake up every day feeling pain in neck and flu-like aches.
Age: 1.5
Sex: F
Vaccine: MMRV
Symptoms: Aphasia, Autism spectrum disorder, Head banging, Immediate post-injection reaction, Insomnia
Clinical narrative: Patient was 19 mos. old at vaccination time-May 2015. She was a completely healthy, talkative toddler. We let her get the MMR vaccine despite multiple warnings and she lost all skills immediately after receiving the vaccine. She stopped responding to her name, stopped talking, she stopped sleeping, she bangs her head day and night.
Age: 1.5
Sex: F
Vaccine: MMRV
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient was 19 mos. old at vaccination time-May 2015. She was a completely healthy, talkative toddler. We let her get the MMR vaccine despite multiple warnings and she lost all skills immediately after receiving the vaccine. She stopped responding to her name, stopped talking, she stopped sleeping, she bangs her head day and night.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Muscular weakness, Pain, Swelling
Clinical narrative: Shot was given very aggressively! Upon leaving clinic I had pain within 5 minutes. Drive home is 45 minutes I could not raise arm to flush toilet. Pain and swelling-limited movement. No strength to lift.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M020101, expiration date: 07-MAR-2019) (dose and route of administration were not reported). There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. As of 22-NOV-2016 all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA004057: MERCK 1610USA004025:Mfr number.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age and gender. Concomitant medications, pertinent medical histories and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M002055, expiry date 11-JUL-2017; lot # M007965, expiry date 15-AUG-2017; lot # M007964, expiry date 15-AUG-2017; lot # M022403, expiry date 01-NOV-2017, lot # M032496, expiry date 02-JAN-2018 (albumin status of rHA (recombinant human albumin)) (lot # and expiry date reported twice); dose and route of administration were not reported) for prophylaxis. The doses of the vaccine were exposed to a temperature excursion of -4.8 degrees Celsius for a time frame of 1 hour 20 minutes (date unspecified). A digital data logger was involved. There were no previous temperature excursions. No adverse effects 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. Sender's Comments:  US-009507513-1611USA013382.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse concerning multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in October 2016 (reported as between 09-OCT-2016 to 21-OCT-2016 ), the patients were vaccinated with improperly stored PNEUMOVAX23 lot # M018766, expiry date: 15-OCT-2017, lot# M038216, expiry date: 09-MAY-2018 (dosing details and route were not reported) for prophylaxis. It was reported that the vaccines were exposed to the temperature of 30.2F during a time frame of 12 days. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003199.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse concerning multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in October 2016 (reported as between 09-OCT-2016 to 21-OCT-2016), the patients were vaccinated with improperly stored ROTATEQ lot # M019706, expiry date: 24-OCT-2017 (dosing details and route were not reported) for prophylaxis. It was reported that the vaccines were exposed to the temperature of 30.2F during a time frame of 12 days. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA003199:
Age: 37.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Started w/a fever up to 104F 1 day after vaccine. Red hot area to immunization site of Pneumococcal vaccine on (L) deltoid.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Patient noticed circular, red rash. Advised to go to primary care MD. Received 10 day course of KEFLEX 500mg (4x daily).
Age: 50.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received influenza and PREVNAR vaccines on right upper arm on 11/15/16. She developed an erythema, pain and swelling on the arm.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: Pt. received 2 mo immunizations PEDIARIX ROTATEQ PEDVAX PREVNAR 13 on 8/24/16. I have no information on autopsy or documented cause of death only that pt. was declared deceased on 8/25/16.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain
Clinical narrative: Bruising, soreness.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Tendonitis
Clinical narrative: Pain upon vaccination, not relieved with Ibuprofen. (L) arm pain continued > 7 days and decreased mobility approximately. MD diagnosed with tendonitis and prescribed prednisone x 1 wk and physical therapy.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Tendonitis, X-ray limb
Clinical narrative: Left shoulder tendonitis began 1 wk after flu vaccine on 10-6-16. Chiropractor visit 10-14-16. PCP visit 10-28-16. Orthopedic visit 11-1-16. Physical Therapy 11-8-16.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain in extremity
Clinical narrative: I received my flu shot in my upper left arm on Oct 19th. Approximately 2 weeks later, I experienced tremendous soreness and lack of mobility in that arm. Almost impossible to take a shirt on or off.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging spinal normal, Pain in extremity, Paraesthesia
Clinical narrative: 10/15-flu vaccination followed by pain in left arm, pain constant for 2 weeks followed by pins and needles feeling by 10/28. Started to have feelings of weakness in left arm. Seeked medical attention in Emergency department on 11/4 than followed up with Neurology 11/9, 11/14, 11/18. Ordered and MRI, EMG.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Nausea, Skin warm
Clinical narrative: Patient called to report she had gone to the ER on 11/25 due to her arm being red and hot. She also reported nausea ER gave her Amoxicillin she said and told her to take BENADRYL. I told her to follow up with her PCP as well and use ice on her arm. It was her left arm.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood culture, Blood test, Chills, Influenza like illness, Pain
Clinical narrative: Chills, body aches --flu like symptoms.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood count abnormal, Inflammation, Inflammatory marker increased, Vaccination site cellulitis
Clinical narrative: Chills, body aches --flu like symptoms.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: Swelling at injection site, lymph nodes are swollen. Being monitored by her oncologist but no treatment (per nurse).
Age: 15.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Facial paralysis
Clinical narrative: Right facial paralysis onset 11/16/16 - Diagnosed with Bell's Palsy.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient reports right shoulder pain and loss in range of motion after influenza IM injection. Was diagnosed with bursitis 9/26/16.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Pyrexia
Clinical narrative: Severe chills and fever of 104.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Pain, Pruritus
Clinical narrative: Giant red spot covering the entire bicep/tricep area above the elbow with severe itching, burning, and pain. This stayed for 4 days. I had to take Benadryl for all 4 days and it only helped a little bit.
Age: 18.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MENB
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Fatigue, Nausea
Clinical narrative: Fatigue, nausea, no appetite, dizziness, diarrhea, and fever.
Age: 18.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MENB
Symptoms: Pyrexia
Clinical narrative: Fatigue, nausea, no appetite, dizziness, diarrhea, and fever.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Patient began experiencing ascending bilateral arm parasthesia on 11/16.  On 11/17 this progressed to her legs with weakness to all extremities.  She presented to ED and was admitted and treated for Guillain Barre Syndrome.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Patient began experiencing ascending bilateral arm parasthesia on 11/16.  On 11/17 this progressed to her legs with weakness to all extremities.  She presented to ED and was admitted and treated for Guillain Barre Syndrome.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Unknown the exact time or date of onset.  Date and time was when patient was seen in the clinic.  Erythema from AC to superior to left elbow.  11.5 inches by 4.5 inches.  Patient reports pain and swelling in arm.  Redness not localized to injection site.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Diarrhoea, Urticaria
Clinical narrative: Hives and diarrhea reported by mother.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II(albumin status:rHA) lot # M000768, expiration date 05-JAN-2018 (dose and route of administration were not reported) for prophylaxis. The vaccine had been stored under the lowest temperature 49.3 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Follow-up information received on 05-DEC-2016. On 05-DEC-2016, a call was placed to the Medical assistant who stated that she would research and send in the patient identifiers and dates of vaccination. No additional information is available.; Sender's Comments: US-009507513-1610USA004834:, MERCK 1609USA013240:Mfr number.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a allied health official and refers to a multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ Lot number M012495, expiration date 09-OCT-2017; Lot # L033693, Expiration date 31-MAY-2017, Lot # L008050, Expiration date 09-NOV-2016; Lot # L006184, Expiration date 13-DEC-2016 for prophylaxis. No adverse effects reported. The vaccine doses were had a temperature excursion of 13.5 Celsius Degrees for 10 hours and 14.8 Celsius Degrees for 43.75 hours. Data logger was unsure. There was no previous temperature excursion. This is one of the three reports received from the same reporter. Follow up information was received on 30-NOV-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: MERCK 1610USA007020:Mfr number.
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 number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date between 08-OCT-2016 and 11-OCT-2016, the patients were vaccinated with improperly stored unspecified dose of ROTATEQ (dosing details were not reported) (lot # M019706, expiry date: 24-OCT-2017) orally for prophylaxis which was stored at temperature of 1 degree centigrade for 4 hours as worst. There were no previous temperature excursions reported. No adverse effects were reported. There was no product quality complaint involved.  Follow up information has been received on 30-NOV-2016, a call was placed to the medical assistant, but he/she was unable to provide any further information. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA005738: US-009507513-1610USA007902:, MERCK 1610USA007903:Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant medications were not reported.  On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored VARIVAX injection, 0.5 ml, subcutaneously, lot# M027343 with expiration date: 01-JUN-2018. Administered doses of VARIVAX were exposed to the temperature of 8.6 Fahrenheit degrees for 25 hours. Data logger was involved. There were no previous excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. Follow up information was received on 05-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: ,MERCK 1610USA009201:Mfr number.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Information was received from a pharmacist on 17-NOV-2016. The pharmacist reported that a patient received a dose of PNEUMOVAX (lot # M037669, expiry 09-MAY-2018) on 14-NOV-2016. Soon after the administration of the vaccine, the patient developed redness at the injection site in the deltoid region, along with some pain, swelling and hardness. The pharmacist reported that the symptoms then spread down near her elbow and "today it has spread to the joint in her inner elbow". The pharmacist reported that the patient has not been sleeping well because of the symptoms. The physician reported that the patient self-administered an unspecified "mild over-the-counter pain reliever to deal with it." The patient also received a dose of AFLURIA (lot and expiration unknown) on the same day (14-NOV-2016) in the same arm. They were able to determine that the reaction started with the PNEUMOVAX23 injection site. The pharmacist reported that the patient had an unspecified pneumococcal vaccine "many years ago" and did not experience any reaction from it. The patient had also received PREVNAR 13 on an unspecified date with no reaction.  No further information was provided regarding this patient. Additional information has been requested. This is one of several reports by the same reporter (1612USA001909, 1612USA001910). Sender's Comments:  US-009507513-1612USA001909: US-009507513-1612USA001910.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Skin lesion
Clinical narrative: Information had been received on 21-NOV-2106 from a nurse regarding a 70 year old female patient with allergy to cephalosporins who received a dose of PNEUMOVAX23 "in August 2016" at her allergist's office. Concomitant medications included LIPITOR, FLONASE, an unspecified thiazide, CLARITIN and PROTONIX. On an unknown date, patient consulted physician because she developed a rash on her legs bilaterally after receiving PNEUMOVAX23. The nurse didn't have any details about the dose of PNEUMOVAX23 that was administered. On an unknown date, the physician did a biopsy of the lesions and believed that the lesions are possibly lichens planus or "bites". The physician documented that the patient's legs are "better" on 11-NOV-2016. Patient's present status was recovering. Patient received unspecified treatment for her adverse event. The nurse was not able to provide many details about this adverse experience because she said, "I just called to ask a quick question". No additional information was provided.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. Since an unknown date, the patient was on ROTATEQ (dose, frequency, route, lot number and expiry date not reported) for propylaxis. The patient inadvertently received a fourth dose ROTATEQ on an unspecified date 6 months after receiving the 3rd dose of ROTATEQ VIAL. No adverse effect reported.   Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information was received from a pharmacist on 17-NOV-2016. The pharmacist reported that a patient informed her that "her sisters all experienced swelling of their entire injection arm" following administration of PNEUMOVAX23 (lot and expiration was unspecified) on an unspecified dates. The sisters were informed by their physicians not to receive the vaccine again. The pharmacist had no other information on these patients. Additional information is not expected. This is one of several reports by the same reporter (MARRS # 1612USA001910, 1611USA009249). Sender's Comments: US-009507513-1612USA001910: US-009507513-1611USA009249.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 18 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Muscle soreness, unable to raise/use arm to full extent.
Age: 85.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient presented to pharmacy 12/6/2016 1 PM to pick up rx.  She ask me to look at the injection site of PREVNAR 13 given on 11/2//2016. Area appeared to be red and slightly swollen, bit painful.  Instructed patient to use ice or  Tylenol if needed.  I sxplained to patient redness was expected with this type of vaccine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site streaking, Injection site swelling
Clinical narrative: Pt called clinic to report that she had a hard raised area around where needle was inserted in her arm with red streaks extending to her elbow.  Pt was advised to take Benadryl and put ice packs on the area and if not better in a couple of days to return to the clinic for revaluation.  Advised to go to the ER if she has trouble breathing or if rash develops.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Paraesthesia oral
Clinical narrative: Patient stated to feel tingling of the tongue within 15 min. Contacted her doctor, which instructed us to give her Benadryl 25mg and monitor the patient. If symptoms worsen to call 911. Patient felt better immediately but we monitored her for one hour, then the patient went home. The pharmacy called her two hours later and the next day and the patient was feeling normal. No further action was needed.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Constipation, Diarrhoea, Mobility decreased, Muscular weakness
Clinical narrative: Per pt 1 week before Thanksgiving, he and his friend ate raw oysters, took Flagyl felt little better. Pt states have not had BM in 5 days, feels constipated, and 4 days muscle weakness, trouble getting up/no strength. Pt stated that he can hardly lift his hands above his shoulders, no pain just weakness. Difficult getting up from sitting position, have thigh pain with trying to get up. Pt is a retired FP physician, move. Pt  reports that the weakness is progressively getting worse. Normally his is a very active 70 yo gentleman. Had diarrhea have resolved. He have been on this same med for ever, no longer on Flagyl.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: Swollen, painful red arm that is still swollen at the time of our meeting at 9 AM this morning; two episodes of vomiting at approx. 3 AM last night.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, painful red arm that is still swollen at the time of our meeting at 9 AM this morning; two episodes of vomiting at approx. 3 AM last night.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Headache
Clinical narrative: Headache, long lasting.  This is day 7 of the headache.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable consumer by way of Claim Letter and Medical Records. This 70-year-old, female patient of an unknown race was injected PREVNAR 13 vaccine 0.5 ml on 31Oct2016 in the left arm through intramuscular route for pneumonia. The lot number was reported as N34936, expiration date was Oct2017 and NDC number was 00005-1971-02. The frequency was unknown. The relevant medical history included chronic lung disease on an unknown date. The concomitant medication and past drug history were unknown. On 31Oct2016, the patient developed cellulitis in the left arm. The relevant lab data was unknown. The action taken with pneumococcal 13-val conj vac (dipht crm197 protein) in response to the event was unknown. The therapeutic measures taken were unknown. As of 02Dec2016, the clinical outcome of the event cellulitis in the left arm was unknown.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cellulitis, Erythema, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer by way of Claim Letter and Medical Records. This 70-year-old, female patient of an unknown race was injected PREVNAR 13 vaccine 0.5 ml on 31Oct2016 in the left arm through intramuscular route for pneumonia. The lot number was reported as N34936, expiration date was Oct2017 and NDC number was 00005-1971-02. The frequency was unknown. The relevant medical history included chronic lung disease on an unknown date. The concomitant medication and past drug history were unknown. On 31Oct2016, the patient developed cellulitis in the left arm. The relevant lab data was unknown. The action taken with pneumococcal 13-val conj vac (dipht crm197 protein) in response to the event was unknown. The therapeutic measures taken were unknown. As of 02Dec2016, the clinical outcome of the event cellulitis in the left arm was unknown.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to an unknown number of patients of unknown age and gender. Medical history and concurrent conditions were not provided.    On an unknown dates, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB therapy type unknown (dose, frequency, route of administration and indication were not reported, lot # L016959 with expiration date: 12-MAR-2018). Concomitant medications were not reported. No adverse events were reported. The administered dose was stored in 47 F for 8 hours. There was no previous temperature excursions. Data logger was not involved. As of 30-NOV-2016, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA003001: US-009507513-1610USA003003:US-009507513-1610USA003004: US-009507513-1610USA003005:US-009507513-1610USA003002: US-009507513-1610USA002738:,MERCK 1610USA003006:Mfr number.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information was received from a pharmacist on 17-NOV-2016. The pharmacist reported that an unspecified number of unspecified patients have experienced redness, swelling, pain and hardness at the injection site following administration of PNEUMOVAX23 (unspecified lot and expiration). The pharmacist reported that she had never seen the reaction spread in any of those patients. The pharmacist had no further information to provided regarding these unspecified patients. Additional information is not expected. This is one of several reports by the same reporter (MARRS # 1611USA009249 1612USA001909). Sender's Comments: US-009507513-1612USA001909: same reporter US-009507513-1611USA009249: source.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant concerning a male patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. The reporter stated that another medical assistant was given order for flu vaccine and the patient was vaccinated with ZOSTAVAX, 0.65 ml, once (lot# and expiry date were not reported) intramuscularly for prophylaxis (wrong vaccine administered) (incorrect route of drug administration). No adverse events were noted by the patient. There were no product quality complaints (PQC) involved.    Additional information has been requested.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt reported a "line" going from the injection point down across his bicep. He said it was hot and painful to touch, but went away after a day or two.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal pain, Swelling
Clinical narrative: Soreness in arm from shoulder to elbow; swollen post 24 hours.  48 hours out, soreness lessening.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Erythema, Hypersensitivity
Clinical narrative: Patient noticed redness after waking up from a nap in which she had been laying on the arm that was injected with PREVNAR 13.  She came to the pharmacy 12/06/2016 and the on duty pharmacist told her to take some ibuprofen. Patient was allergic to Benadryl so it was not recommended. Patient came back on 12/7/2016 and I told to go to the doctors office.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Chills all day; tired. arm swollen and red 24 hours post vaccine.  12/7/16 - chills gone - mobility better, less sore.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Blister, Erythema, Gait disturbance, Induration, Pruritus
Clinical narrative: Extreme swelling, redness, hardness, bumps, blisters and oozing. Lots of pain resulting in difficulty walking.  Severe itchiness.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Rash, Swelling, Wound secretion
Clinical narrative: Extreme swelling, redness, hardness, bumps, blisters and oozing. Lots of pain resulting in difficulty walking.  Severe itchiness.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling and heat in a circle about 2"x3" just above elbow.... pt applying cold packs every 2 hours and taking acetaminophen as needed.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Biopsy artery normal, Blindness unilateral, C-reactive protein increased, Headache
Clinical narrative: Very gradually got stiffness in shoulders and hips. Had trouble end of golf season to pick ball up from ground. Slowly got worse until July 2016: diagnosis PMR and September 2016 diagnosis GCA.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint stiffness, Musculoskeletal stiffness, Night sweats, Pain of skin, Polymyalgia rheumatica
Clinical narrative: Very gradually got stiffness in shoulders and hips. Had trouble end of golf season to pick ball up from ground. Slowly got worse until July 2016: diagnosis PMR and September 2016 diagnosis GCA.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Temporal arteritis
Clinical narrative: Very gradually got stiffness in shoulders and hips. Had trouble end of golf season to pick ball up from ground. Slowly got worse until July 2016: diagnosis PMR and September 2016 diagnosis GCA.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Areflexia, Grip strength decreased, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Tingling in fingers on 10/18. 10/19 Numbness beginning in toes; not feeling well resulting in ER visit. 10/20 Weakness in legs progressing to inability to walk.  Called primary care physician and went in - saw physician's assistant.  Unable to walk in - had to use a wheelchair.  Unable to grasp a pen or sign my own name.  PA was unable to pin down the issue and indicated return to ER if symptoms continued to progress.  Referral given to neurologist. 10/21/16 Symptoms continued to progress up the body - moved upward to thighs. Returned to ER - no reflexes present in lower extremities.  Suspected Guillain Barre Syndrome and admitted to ICU.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Intensive care, Malaise, Muscular weakness, Paraesthesia
Clinical narrative: Tingling in fingers on 10/18. 10/19 Numbness beginning in toes; not feeling well resulting in ER visit. 10/20 Weakness in legs progressing to inability to walk.  Called primary care physician and went in - saw physician's assistant.  Unable to walk in - had to use a wheelchair.  Unable to grasp a pen or sign my own name.  PA was unable to pin down the issue and indicated return to ER if symptoms continued to progress.  Referral given to neurologist. 10/21/16 Symptoms continued to progress up the body - moved upward to thighs. Returned to ER - no reflexes present in lower extremities.  Suspected Guillain Barre Syndrome and admitted to ICU.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Wheelchair user
Clinical narrative: Tingling in fingers on 10/18. 10/19 Numbness beginning in toes; not feeling well resulting in ER visit. 10/20 Weakness in legs progressing to inability to walk.  Called primary care physician and went in - saw physician's assistant.  Unable to walk in - had to use a wheelchair.  Unable to grasp a pen or sign my own name.  PA was unable to pin down the issue and indicated return to ER if symptoms continued to progress.  Referral given to neurologist. 10/21/16 Symptoms continued to progress up the body - moved upward to thighs. Returned to ER - no reflexes present in lower extremities.  Suspected Guillain Barre Syndrome and admitted to ICU.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Screaming, X-ray
Clinical narrative: Screamed for 7 hours.  Had fever of 102.5. No wet diapers.  Went to ER 10/6/16.
Age: 32.0
Sex: M
Vaccine: ANTH, FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling, pain, hot skin, redness.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site inflammation, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt stated her left arm by the injection site of PNEUMOVAX 23 got reaaly big, swollen, inflammed & painful.  It spread all the way to the back side.  She also developed high fever, chills until Sunday.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, tenderness, swelling, at injection site.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Chest X-ray, Decreased appetite, Irritability, Rash generalised, Urticaria
Clinical narrative: One hour after vaccination a rash was noted in the thighs, back, no fever, no problems breathing. About 4 hours later after mother called to report the rash. 8 hours later mother called the PCP and reported the rash is from "head to toe" patient was a little bit cranky, no problems breathing no fever, some decrease appetite. There was a big "welt" close to the side of the injections. She was asked to report to emergency room. Patient was given Prednisone and Benadryl one dose of each. Follow up phone call the following morning mother reported less rash and baby is back to normal. On examination today the baby looked well with faint macular few papular rash on the trunk, and cheek. There was about 1 ½ inch circular rash left thigh close to the site of injection and about and inch circular rash on the right thigh. She was prescribe hydroxyzine and Epipen.  And was referred to an allergist.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Full blood count normal, Petechiae, Platelet count normal, Rash, Rash papular
Clinical narrative: Full torso rash, pinpoint red papules with some petechiae noted in neck area.  Occurred after 3 weeks from vaccine.  Seems longer than the usual 2 weeks.  Otherwise child acting normal.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Cold sweat, Dizziness, Injected limb mobility decreased, Injection site pain
Clinical narrative: Got out of bed to go to bathroom. Felt very dizzy and weak. Lowered myself to floor to avoid bad fall. Drenched with cold sweat and very nauseated. Arm of shot site extremely painful. Difficult to lift arm. Made it back to bed. Slept OK. Same thing happened (above: weakness, etc.) when I got up the next a.m. Symptoms not quite as severe but still had nausea & cold sweats, weakness, shakiness.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Tremor
Clinical narrative: Got out of bed to go to bathroom. Felt very dizzy and weak. Lowered myself to floor to avoid bad fall. Drenched with cold sweat and very nauseated. Arm of shot site extremely painful. Difficult to lift arm. Made it back to bed. Slept OK. Same thing happened (above: weakness, etc.) when I got up the next a.m. Symptoms not quite as severe but still had nausea & cold sweats, weakness, shakiness.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: PATIENT FACE TURNED RED shortly after receiving Pneumovax 23. Patient breathing and heart beat were normal. So I provided patient with Benadryl 50 mg and instructed her to wait longer in lounge. 10 minutes later patient reaction was worsening, both face and neck were getting more red. So I gave the patient some cold pads to apply on her face and neck. Ten minutes later patient was somewhat stable, no swelling or difficulty breathing. Another pharmacist followed up with patient and gave her 2*25 mg capsules to take one while waiting in store and take the other 6 hours later. Patient showed up in store next day and she did not have any allergy symptoms.