chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Physician referring to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA 25/0.5 lot # reported as: L002717 expiration date: 02-JUN-2017 (dose and administration route were not provided). No concomitant therapies were reported, neither way any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Physician referring to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # reported as: L018501 expiration date: 22-JUN-2017 (dose and administration route were not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown ages and genders. No medical history or concurrent conditions were reported. On 20-OCT-2015, the patients were vaccinated with ZOSTAVAX, with lot # L028279 and expiration date as 28-OCT-2016 (dosage, frequency and route of administration were not reported). No concomitant therapies were reported. On 21-OCT-2015, a days after onset of therapy both the patients experienced injection site reactions. The outcome of injection site reaction was unknown. No causal relationship was provided between the events and therapy with ZOSTAVAX. This is one of the several reports from the same source. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chest pain, Electrocardiogram abnormal, Joint warmth, Myalgia
Clinical narrative: Telephone contact 3/8/12 am SUBJECTIVE/OBJECTIVE: Patient called clinic today to report the following symptoms. Awakened this morning with severe joint pain primarily to elbows and hips. He also reports fever, but not documented with temperature. His joints are not particularly warm to touch, no erythema. He was muscle aches to a lesser extent. He took two of his hydrocodone 10/325 this morning and 2 about 1300. He states it didn't touch it at all. Patient received pneumococcal vaccine approximately 48 hours ago. He also reports one episode of vomiting this morning and mild nausea during the day. ASSESSMENT: DDX: Adverse reaction to pneumococcal vaccine vs viral infection. Told patient he can take supplemental TYLENOL/acetaminophen up to maximum of 4000 mg per day to include the acetaminophen he gets with is hydrocodone. Recommended hot batch to help with joint pain or warm compresses. I told patient if he develops any shortness of breath/tightness in throat or eyes, he should go to ER immediately. If this has worsened tomorrow, he should report to the ER. Information given to patient on how to fill our VAERS report with the CDC. Patient verbalized understanding, I will follow up with patient on Monday to see how he is doing at that time. Employee notified of situation and is aware of that patient may present to ER at some point. The patient/caregiver agreed with the plan. 3/9/12 pm Spoke with patient, is in ER. He reported that originally had aches and fever, every joint in body hurt. Today when woke up all the pain was centralized in chest. Is currently in ER, and apparently a cardiac specialist is on his way for further evaluation. Did find EKG abnormalities. Has been taking more hydrocodone than normal due to the increased pain. Had a morphine shot this am at ER. Patient will keep this hospital abreast of outcome. A: Adverse reaction from recent PNEUMOVAX vaccine? See 3/8/12 associated information note. P: Thanked patient for the update: Expressed our concern for this patient and he thanked us for our time.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Pyrexia, Vaccination complication, Viral infection, Vomiting
Clinical narrative: Telephone contact 3/8/12 am SUBJECTIVE/OBJECTIVE: Patient called clinic today to report the following symptoms. Awakened this morning with severe joint pain primarily to elbows and hips. He also reports fever, but not documented with temperature. His joints are not particularly warm to touch, no erythema. He was muscle aches to a lesser extent. He took two of his hydrocodone 10/325 this morning and 2 about 1300. He states it didn't touch it at all. Patient received pneumococcal vaccine approximately 48 hours ago. He also reports one episode of vomiting this morning and mild nausea during the day. ASSESSMENT: DDX: Adverse reaction to pneumococcal vaccine vs viral infection. Told patient he can take supplemental TYLENOL/acetaminophen up to maximum of 4000 mg per day to include the acetaminophen he gets with is hydrocodone. Recommended hot batch to help with joint pain or warm compresses. I told patient if he develops any shortness of breath/tightness in throat or eyes, he should go to ER immediately. If this has worsened tomorrow, he should report to the ER. Information given to patient on how to fill our VAERS report with the CDC. Patient verbalized understanding, I will follow up with patient on Monday to see how he is doing at that time. Employee notified of situation and is aware of that patient may present to ER at some point. The patient/caregiver agreed with the plan. 3/9/12 pm Spoke with patient, is in ER. He reported that originally had aches and fever, every joint in body hurt. Today when woke up all the pain was centralized in chest. Is currently in ER, and apparently a cardiac specialist is on his way for further evaluation. Did find EKG abnormalities. Has been taking more hydrocodone than normal due to the increased pain. Had a morphine shot this am at ER. Patient will keep this hospital abreast of outcome. A: Adverse reaction from recent PNEUMOVAX vaccine? See 3/8/12 associated information note. P: Thanked patient for the update: Expressed our concern for this patient and he thanked us for our time.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 27-DEC-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L031066, expiration date 18-AUG-2017; dosage, route and dose number were unknown). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested,
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On17-DEC-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L031066, expiration date 18-AUG-2017; dosage, route and dose number were unknown). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Blood culture, Erythema, Full blood count, Metabolic function test
Clinical narrative: Patient was seen on 12/18/2015 and was given a PCV13 vaccine. Pt tolerated well. Patient stated approx. an hour later at home she started to develop pain in her right arm. States it began to swell and had redness. Pt then waited and cane into Urgent Care on 12/22/2015 after developing a fever. She had erythema and early blistering over 10x20 cm area with increased warmth. She was given pain meds. Her WBC was high. She was  given IV Fluids for her fever and discharged home using cool compresses and cortisone cream. Pt then followed up with PCP on 12/23/2015 and 12/28/2015. Visit on 12/28/2015 stated it was starting to improve. Pt still had redness and pain. Pt states she had PNEUMOVAX 23 in past and she never had a reaction to that vaccine.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Skin warm, White blood cell count increased
Clinical narrative: Patient was seen on 12/18/2015 and was given a PCV13 vaccine. Pt tolerated well. Patient stated approx. an hour later at home she started to develop pain in her right arm. States it began to swell and had redness. Pt then waited and cane into Urgent Care on 12/22/2015 after developing a fever. She had erythema and early blistering over 10x20 cm area with increased warmth. She was given pain meds. Her WBC was high. She was  given IV Fluids for her fever and discharged home using cool compresses and cortisone cream. Pt then followed up with PCP on 12/23/2015 and 12/28/2015. Visit on 12/28/2015 stated it was starting to improve. Pt still had redness and pain. Pt states she had PNEUMOVAX 23 in past and she never had a reaction to that vaccine.
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Injection site pain, Rash
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a female patient of unknown age. Concurrent conditions or pertinent medical history were not reported. On an unknown date in November 2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # L020482, expiration date: 02-SEP-2016) (dose and frequency were unspecified). Concomitant therapies included Influenza virus vaccine (unspecified) in the opposite arm. On an unspecified date in November 2015, the patient called to the pharmacist to inform her that her arm was tender to the touch at the injection site (injection site pain) and that she developed rash under both arms in the breast area (rash). No product quality complaint was involved. At the time of the report, the outcome of injection site pain and rash was unknown. The relatedness of ZOSTAVAX with the adverse events was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. It was reported that on 23-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L003188, expiration date 06-JUL-2016), (dose and route were not provided). Concomitant therapies were not provided. No adverse effects were reported. This is one of two reports from the same source (MARRS # 1512USA012013). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.MA) concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. It was reported that on 19-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L003188, expiration date 06-JUL-2016), (dose and route were not provided). Concomitant therapies were not provided. No adverse effects were reported. This is one of two reports from the same source (MARRS # 1512USA013609). 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 registered nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 02-NOV-2015, the patients were vaccinated with oral ROTATEQ, Lot number L008054, expiration date 30-NOV-2016, Lot # L008996, expiration date 01-DEC-2016. No adverse event was reported. The outcome of the event was unknown. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of nausea in a adult male patient who received Hepatitis A vaccine. Concurrent medical conditions included allergic reaction to antibiotics and drug allergy. Concomitant products included Synthroid, colchicine, IMURAN, lamotrigine, PRILOSEC, testosterone, MIRAPEX, B12 and vitamin nos. On an unknown date, the patient received Hepatitis A at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced nausea and sweating. On an unknown date, the outcome of the nausea and sweating were unknown. It was unknown if the reporter considered the nausea and sweating to be related to Hepatitis A vaccine. Additional details were received as follows: The patient experienced reactions to various drugs (refer case US2015GSK181323 for further details).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 19-AUG-2015, the patient was vaccinated with GARDASIL 9 dose number 1, lot #, expiry date, dose, route unknown. The second dose was received on 19-OCT-2015, and then the third dose was received on 21-DEC-2015. The reporter stated that the third dose of GARDASIL 9 was administered earlier than recommended. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to unspecified number of patients of unknown age and gender. Past medical history and concurrent conditions were not reported. The health care worker reported that, the patients were vaccinated with improperly stored doses PNEUMOVAX 23 (lot, batch # K020800, expiry date 05-JUN-2016, dose, strength, dose number, vaccination site, route of administration unspecified) since her initial call on 29-OCT-2015. Concomitant medications were not provided. No adverse events were reported. No further information was provided. Product quality complaint (PQC) was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On an unknown date, since 26-OCT-2015, the patients were vaccinated with improperly stored doses of VAQTA lot # L016427, expiration date: 02-JUN-2017 (administration route and doses were not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 09-DEC-2015, a dose of PROQUAD (Merck) lot/batch # reported as L014405, expiration date 23-OCT-2016 was improperly exposed to - 8.1 degrees Celsius for 2 hours and 35 minutes. Then on dates from 22-DEC-2015 to 28-DEC-2015, the same dose of PROQUAD (Merck) was improperly exposed to - 2.1 degrees Celsius for 144 hours. Then on 30-DEC-2015, this dose of PROQUAD (Merck) (dose not reported) was subcutaneously administered to the patient. No known adverse effects. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients (age and gender were not reported). On unspecified dates, the patients were vaccinated with doses of PNEUMOVAX 23 (dose, dose #, route and application site were not reported). The injection of PNEUMOVAX 23 was painful for those patients. Outcome of the adverse event was unknown. The relatedness between painful injection and PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a male patient of unknown age, reporter's son. There was no information regarding the patient's medical history, concurrent conditions or concomitant medications reported. On an unspecified date in 2015 (also reported as "a few weeks ago"), the patient was vaccinated with reconstituted VARIVAX (Merck) (dose, route of administration, lot # and expiry date were not specified) that was stored in the refrigerator in a syringe for 18 hours prior to administration. No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Therapeutic response unexpected
Clinical narrative: Information has been received from currently 34 year old female consumer concerning herself with psoriasis, diabetes, polycystic ovary disease and bipolar disorder. The patient was not pregnant. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot #, expiration date, dose and route unspecified). The patient noted that after received GARDASIL, she experienced alleviation of her symptoms from Polycystic Ovarian Syndrome, which she claimed she no longer experienced (Therapeutic response unexpected). She was unsure if the vaccine had an effect on the remission of the disorder. In 2007, the patient was vaccinated with VARIVAX (Merck). She experienced weight loss and a faster metabolism (capture into MARRS# 1512USA012074). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Inappropriate schedule of drug administration, Pain in extremity, Pruritus, Urine analysis
Clinical narrative: Information has been received from currently 34 year old female consumer concerning herself with psoriasis, diabetes, polycystic ovary disease and bipolar disorder. The patient was not pregnant. In 2007, the patient was originally vaccinated with a dose of VARIVAX (Merck), 1 shot (lot # and expiration date unspecified), subcutaneously. Concomitant therapies included lisinopril (manufacturer unknown), insulin, risperidone, unspecified birth control medicine and unspecified nasal spray. On an unspecified date, after receiving the vaccine, she began to experience itchiness and pain in her arms which had been afflicted with a severe case of psoriasis since childhood. The next day she noticed that the psoriasis had cleared largely from her arms, with pustule and plaque removal. Over time she noticed the psoriasis in her arms began to return, so she began to take VARIVAX (Merck) to clear flare ups and hoped to remove the psoriasis from the rest of her body. On an unknown date, she also experienced weight loss, and a faster metabolism which had helped her diabetes. No treatment was given for weight loss and faster metabolism. On an unspecified date, blood and urine studies were performed, but the results were not provided. After administered 10 shots of VARIVAX (Merck) (detail information concerning the dose and frequency unspecified) over the subsequent years, her psoriasis had been in remission and had not returned as a result of any normal triggers such as stress or diet. The patient had been sharing the results with her doctor. The outcome of weight loss and faster metabolism was not resolved (It was also reported that the events reappeared after reintroduction of VARIVAX (Merck)). The patient reported the events in hopes of having her results shared and that the product could be investigated for use in treating psoriasis and other inflammatory related issues and also wanted to submit her documentation. The patient also noted that after receiving GARDASIL, she experienced alleviation of her symptoms from Polycystic Ovarian Syndrome (capture into MARRS # 1601USA000100). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Weight decreased
Clinical narrative: Information has been received from currently 34 year old female consumer concerning herself with psoriasis, diabetes, polycystic ovary disease and bipolar disorder. The patient was not pregnant. In 2007, the patient was originally vaccinated with a dose of VARIVAX (Merck), 1 shot (lot # and expiration date unspecified), subcutaneously. Concomitant therapies included lisinopril (manufacturer unknown), insulin, risperidone, unspecified birth control medicine and unspecified nasal spray. On an unspecified date, after receiving the vaccine, she began to experience itchiness and pain in her arms which had been afflicted with a severe case of psoriasis since childhood. The next day she noticed that the psoriasis had cleared largely from her arms, with pustule and plaque removal. Over time she noticed the psoriasis in her arms began to return, so she began to take VARIVAX (Merck) to clear flare ups and hoped to remove the psoriasis from the rest of her body. On an unknown date, she also experienced weight loss, and a faster metabolism which had helped her diabetes. No treatment was given for weight loss and faster metabolism. On an unspecified date, blood and urine studies were performed, but the results were not provided. After administered 10 shots of VARIVAX (Merck) (detail information concerning the dose and frequency unspecified) over the subsequent years, her psoriasis had been in remission and had not returned as a result of any normal triggers such as stress or diet. The patient had been sharing the results with her doctor. The outcome of weight loss and faster metabolism was not resolved (It was also reported that the events reappeared after reintroduction of VARIVAX (Merck)). The patient reported the events in hopes of having her results shared and that the product could be investigated for use in treating psoriasis and other inflammatory related issues and also wanted to submit her documentation. The patient also noted that after receiving GARDASIL, she experienced alleviation of her symptoms from Polycystic Ovarian Syndrome (capture into MARRS # 1601USA000100). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician referring to a female patient of unknown age. Concurrent conditions and medical history of the patient were not reported. On 14-DEC-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K009198, expiry date 27-SEP-2015) (dose, route unspecified) (Expired vaccine used). The last menstrual period (LMP) was 02-JUN-2015 and expected delivery of date (EDD) was 08-MAR-2016. The patient was in 30 weeks gestation at the time of ZOSTAVAX administration (Drug exposure during pregnancy, third trimester) (Product used in unapproved population). The pregnancy outcome was unknown. No adverse effects have been reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse via company representative regarding a female patient of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with GARDASIL 9. No concomitant medication was reported. It was reported that the patient was recently found to be pregnant on an unspecified date. The LMP (Last Menstrual Period) and EDD (Estimated date of delivery) was unknown. The patient visited physician office to seek medical attention. The outcome of the event was unknown. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 2 year old patient of unknown gender with no concurrent condition or medical history reported. On 15-DEC-2015, the patient was vaccinated with a dose of PROQUAD (Merck) (subcutaneous injection, lot # I011080) and VARIVAX (Merck) (subcutaneous injection, lot# I002868) (overdose). No concomitant therapy was reported. The nurse did not have access to the expiration dates of the doses at the time of the call. The patient had not experienced an adverse effect. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates the patients were vaccinated with improperly stored PROQUAD (Merck) (Lot # K018144 with expiration date 10-APR-2016, Lot # L026728 with expiration date 15-JAN-2017, dose and route not reported). Information regarding concomitant  medications was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3, FLUX, FLUX
Symptoms: Back pain, Injection site pain, Muscle strain, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: Pt first called office 10/27/15 c/o of pain at injection site, left shoulder, across back and up neck pain.  'Feels like pulled muscle'.  Was seen at Urgent Care 10/28/15, prescribed Mobic and given Physical Therapy referral.  Pt came back to Urgent Care 11/21/15, mostly left arm tingling and paresthesias.  Seems to be improving with physical therapy.  Office visit 12/3/15, to address the pain.  Pt referred to Rheumotologist the following day, 12/4/15 Plan: R Shoulder Left 2 + Vw; XR Humerus Left 2 + Vw; Ambulatory referral to Neurology. RTC IN 6 WKS  CONT WITH AGGRESSIVE PHY THERAPY  NEURO CONSULT  F/u visit w/ Dr. on 12/10/15, MRI done 12/19/15.  F/u visit w/ Dr. to discuss MRI results. 12/24/15
Age: 63.0
Sex: F
Vaccine: FLU3, FLUX, FLUX
Symptoms: Paraesthesia
Clinical narrative: Pt first called office 10/27/15 c/o of pain at injection site, left shoulder, across back and up neck pain.  'Feels like pulled muscle'.  Was seen at Urgent Care 10/28/15, prescribed Mobic and given Physical Therapy referral.  Pt came back to Urgent Care 11/21/15, mostly left arm tingling and paresthesias.  Seems to be improving with physical therapy.  Office visit 12/3/15, to address the pain.  Pt referred to Rheumotologist the following day, 12/4/15 Plan: R Shoulder Left 2 + Vw; XR Humerus Left 2 + Vw; Ambulatory referral to Neurology. RTC IN 6 WKS  CONT WITH AGGRESSIVE PHY THERAPY  NEURO CONSULT  F/u visit w/ Dr. on 12/10/15, MRI done 12/19/15.  F/u visit w/ Dr. to discuss MRI results. 12/24/15
Age: 63.0
Sex: F
Vaccine: FLU3, FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Pt first called office 10/27/15 c/o of pain at injection site, left shoulder, across back and up neck pain.  'Feels like pulled muscle'.  Was seen at Urgent Care 10/28/15, prescribed Mobic and given Physical Therapy referral.  Pt came back to Urgent Care 11/21/15, mostly left arm tingling and paresthesias.  Seems to be improving with physical therapy.  Office visit 12/3/15, to address the pain.  Pt referred to Rheumotologist the following day, 12/4/15 Plan: R Shoulder Left 2 + Vw; XR Humerus Left 2 + Vw; Ambulatory referral to Neurology. RTC IN 6 WKS  CONT WITH AGGRESSIVE PHY THERAPY  NEURO CONSULT  F/u visit w/ Dr. on 12/10/15, MRI done 12/19/15.  F/u visit w/ Dr. to discuss MRI results. 12/24/15
Age: 67.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Rotator cuff syndrome
Clinical narrative: Pain and stiffness in the shoulder.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Pruritus, Skin reaction
Clinical narrative: Shoulder pain on the left side where the Tdap vaccine was received. Severe skin reaction: itching, dark redness.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got the Shingles. It was diagnosed as a mild case.
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Bedridden, Diarrhoea, Impaired work ability
Clinical narrative: Client reports numerous episodes of diarrhea x 4 days after receiving vaccine on 12-30-15. Client states was unable to go to work and was bedridden. Denies vomiting, fever, etc.
Age: 58.0
Sex: M
Vaccine: DTAP, FLUX, MMR, VARCEL
Symptoms: Pain, Pyrexia, Varicella post vaccine
Clinical narrative: FEVER, BODY ACHES AND CHICKENPOX.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Crying, Depressed level of consciousness, Yawning
Clinical narrative: Excessive crying, inconsolable, excessive yawning, depressed sensorium.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Feeling hot, Pain, Swelling
Clinical narrative: Tdap vaccine given on 12/22/15 - client called 12/24/15 c/o s/s of swelling, warmth pain to bruising.
Age: 11.0
Sex: M
Vaccine: FLUN4, HEP, HPV4, IPV, MMRV, MNQ, TDAP
Symptoms: Fall, Hyperhidrosis, Pallor, Presyncope, Skin abrasion
Clinical narrative: Vasovagal response after immunizations given.  Child was ashen, diaphoretic and fell to floor.  Minor abrasion to face due to fall on carpet. Given juice, cookies. Child responsive. Pulse 60bpm.  Assisted to sitting position after 5 minutes. Child ambulatory and alert upon discharge at 12:22 PM.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Herpes zoster, Nausea, Pyrexia
Clinical narrative: Headache, nausea, chills.  Symptoms continued with fever. Rash developed on 12/17/15.  Diagnosed by Urgent Care with Shingles on 12/22/15.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Headache, nausea, chills.  Symptoms continued with fever. Rash developed on 12/17/15.  Diagnosed by Urgent Care with Shingles on 12/22/15.
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Pain in (L)/ shoulder about 8 hours after flu shot. Seen family doctor and referred to an orthopedic doctor and doing physical therapy.
Age: 50.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Laboratory test, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Pain in (L)/ shoulder about 8 hours after flu shot. Seen family doctor and referred to an orthopedic doctor and doing physical therapy.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient states that her arm has ached since receiving the flu vaccine.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Panic attack
Clinical narrative: Starting that evening and he was skin transiting some leg pain and started having panic attacks or surrounding.  He's never had any trouble with panic before.  He is his usual behavior continued for a couple days.  Mother looked this up on the computer and found that other people had similar reactions.
Sex: U
Vaccine: HEPA
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. The patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA lot # L004742, expiration date 22-SEP-2016 (dose and routes of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAP
Symptoms: Crying, Discomfort, Glassy eyes, Pyrexia
Clinical narrative: Red glassy eyes, fever of 104F, discomfort, crying for 5 hours.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reports she did not experience any symptoms the day of the vaccination. Patient reports on Saturday she noticed the injection site became red, itchy, and puffy. Patient reports she has been scratching the area due to the area being itchy. Patient reports the puffiness has resolved but the redness did enlarge in size. Patient has not tried any OTC treatment for the redness or itching. Patient denies rash on any other part of her body.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, RV1, UNK
Symptoms: Haematemesis
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of vomiting blood in a 2-month-old male patient who received PEDIARIX. Co-suspect products included ROTARIX. In 2015, the patient received PEDIARIX and ROTARIX (oral). In 2015, 30 min after receiving PEDIARIX and ROTARIX, the patient experienced vomiting blood (serious criteria GSK medically significant). On an unknown date, the outcome of the vomiting blood was unknown. It was unknown if the reporter considered the vomiting blood to be related to PEDIARIX and ROTARIX. Additional details were provided as follows: The patient also received other non-GSK vaccines (not further specified) along with PEDIARIX and ROTARIX. About half an hour after receiving the PEDIARIX and ROTARIX, the patient experienced blood in vomit. The patient visited emergency room, but he was not kept there.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pain
Clinical narrative: (L) arm sore since PCV13 given. Sore x 4 weeks. Initially swollen, hard and red at site. Now just painful at site. ROM is painful. Will be treated w/massage, ROM exercises.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: (L) arm sore since PCV13 given. Sore x 4 weeks. Initially swollen, hard and red at site. Now just painful at site. ROM is painful. Will be treated w/massage, ROM exercises.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Decreased appetite, Eye movement disorder, Musculoskeletal stiffness
Clinical narrative: Per mother, about 16 hrs. after vaccination, pt. woke up, w/stiffening and eyes rolled back, lasted for < 1 min. no cyanosis noted. Also, less appetite prior to episode. Per mother, pt. felt worsening but no fever documented.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 19 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was administered pediatric dose of VAQTA (lot number and expiration date was not provided) due to a human error. No adverse effects reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Flushing, Injection site induration, Peripheral swelling, Rash
Clinical narrative: Vaccine administered on 12/16. Patient reported that her face and chest became flushed that evening. The next day she noticed bruising with some induration at injection site with some arm swelling. She said she had a rash develop on 12/20 that lasted for a day.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Peripheral swelling
Clinical narrative: Approximately 18 hr post vaccination arm became bright red, swollen, and bruised.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Neck pain, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Arm was sore for 2 days then resolved. Was fine for 3 weeks then dev soreness again in same location, swollen, red, very tender. Pain radiates into neck. Started on KEFLEX no improvement. Sent to ER and given IV ABS and changed to clindamycin.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Raised red rash at injection site day after approx 3-4" across, somewhat painful. Week later it was 2" across less red some hardness and soreness at site. 12/29/2015 all redness and soreness gone.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Haematology test normal, Headache, Injection site pain, Injection site pruritus
Clinical narrative: Dizziness, HA noc 12/31 - continued HA, dizz with PAIN, SWELLING, Warm itching local site 1/1.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Nuclear magnetic resonance imaging
Clinical narrative: Dizziness, HA noc 12/31 - continued HA, dizz with PAIN, SWELLING, Warm itching local site 1/1.
Age: 25.0
Sex: F
Vaccine: HEP, HEPA, MMR
Symptoms: Asthenia, Dizziness, Immediate post-injection reaction, Nausea, Pallor
Clinical narrative: Syncope resulted immediately after vaccination, lasted 5 seconds. Then seizure activity (decerebrate/decorticate movements of limbs) for 5 seconds. Nausea afterwards, pallor, weakness and dizziness. Resolved after 10 minutes of rest, juice and crackers.
Age: 25.0
Sex: F
Vaccine: HEP, HEPA, MMR
Symptoms: Seizure, Syncope
Clinical narrative: Syncope resulted immediately after vaccination, lasted 5 seconds. Then seizure activity (decerebrate/decorticate movements of limbs) for 5 seconds. Nausea afterwards, pallor, weakness and dizziness. Resolved after 10 minutes of rest, juice and crackers.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pyrexia, Swelling, Tenderness
Clinical narrative: Swelling, redness, tenderness, pain, low-grade fever. Within 2 hours after injection, swelling and redness extended over right deltoid to 15.38 cm. Within 24 hrs. symptoms worsened extending down upper arm to anti-cubital fossa -26.9 cm. Self treated with ice x 24hrs, then cold and warm compress, Acetaminophen PO. Symptoms subsided in 5-6 days.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Cluster headache, Dizziness, Echocardiogram, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Dizziness - 7 wks muscle weakness 2 wks. Cluster headaches (left) 4 wks.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Dizziness - 7 wks muscle weakness 2 wks. Cluster headaches (left) 4 wks.
Age: 46.0
Sex: F
Vaccine: FLUR3
Symptoms: Abdominal pain upper, Diarrhoea, Musculoskeletal discomfort, Oropharyngeal discomfort
Clinical narrative: Throat discomfort, diarrhea, stomach ache, neck discomfort.
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Pt. received flu vaccine IM, then swooned and fainted.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Hypoaesthesia, Lip swelling, Mouth swelling, Swelling face
Clinical narrative: At 3:00 am difficult swallowing - swollen mouth lips as time went on numbness in nose, both cheeks. 8:00 pm, whole face swollen, my physician called, asked if I needed 911 or difficulty breathing, I said no. Medication ordered. MEDROL 4 mg Dose Pak, I was told not to take vaccine again.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Muscular weakness, Nuclear magnetic resonance imaging, Tenderness
Clinical narrative: Limited range of motion (L) arm. Can't pick anything heavy up, tender to touch.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Muscular weakness, Pain, Paraesthesia
Clinical narrative: On 12-17-15 patient returned to pharmacy to show a noticeable "hardness" at immunization site (no inflammation). She complains of severe pain when using arm above chest high with weakness and tingling of 3rd, 4th and 5th digits. Denies any other trauma to arm.
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Lethargy, Muscular weakness, Oedema, Pain
Clinical narrative: Pain; Redness, Hot skin, Fever, Lethargy, Edema, Loss of Muscle control near injection site.
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: Pain; Redness, Hot skin, Fever, Lethargy, Edema, Loss of Muscle control near injection site.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Lymphadenopathy, Oropharyngeal pain, Streptococcus test negative, Swollen tongue
Clinical narrative: Felt tongue was swollen, lymph nodes felt swollen, sore throat.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of an unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 16-DEC-2015 the patient was vaccinated with an expired dose of M-M-R II. lot# j014875, expiration date: 21-NOV-2015 (dose and route of administration were not reported). There were no adverse effects reported. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling, Herpes zoster
Clinical narrative: This spontaneous report was received from a male consumer of unknown age, referring to himself. The patient had no known drug reactions/allergies and with no relevant medical history. On 10-SEP-2014, the patient was vaccinated with ZOSTAVAX one time vaccine (route, lot # and expiration date were not provided). The patient did not have any concomitant medication. The patient stated that he got shingles on 03-JAN-2015, he had little scratch on forehead and on 04-JAN-2015, reported as the next day, his left eye was swollen, he could not open his left eye. On 06-JAN-2015, reported as 3 days later, the patient saw a dermatologist, who prescribed him an Valacyclovir and his eye doctor prescribed ZIRGAN. It was also reported that a blood test was performed 2 months ago (results were not provided) and no PQC was involved. At the time of the report, the outcome of shingles and eye swelling was unknown. The reporter did not provide a causality assessment for this case. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. No historical or concurrent conditions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L024122. expiry: 30-DEC-2016). No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of two reports received from the same reporter. Additional information is not expected as consent for contact was denied
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a multiple unspecified patients. No concurrent or historical conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L001312, expiration date 24-FEB-2017) doses, routes, anatomical locations were not reported. No concomitant medications were reported. No adverse effects were reported. No further information was provided. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event, Product lot number issue
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL expiration date 14-SEP-3017 (doses and routes of administration were not reported). The reporter reported GARDASIL lot # I019287, which was not valid for GARDASIL. However lot # I019287 is valid for GARDASIL 9. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with non pertinent medical history. The patient drug reactions included Neomycin allergy. On 18-DEC-2015, the patient was vaccinated with ZOSTAVAX (lot # L027322, expiration date: 21-OCT-2016, dose and route of administration were not reported), in the left arm, as the patient's husband had shingles. There was none concomitant medications. In December 2015 (reported as a couple days later), the injection site began to get red. On 21-DEC-2015, the patient went to her primary doctor's office, who told her that the rash was normal after receiving the ZOSTAVAX. On 28-DEC-2015, the patient went to the pharmacist, because the rash was spreading to both arms, her stomach, to more areas of her body and it was not getting better, and it was starting to welt. None lab diagnostic studies were performed. The patient was using unspecified, over the counter cortisone cream, but it was not helping the rash. The outcome of the events was unknown. The patient sought medical attention via visiting the primary doctor's office and the pharmacist. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Hyperaesthesia, Injection site discolouration, Injection site erythema
Clinical narrative: 12-28 - patient complains of burning hot red, sensitive to touch. 12-29 - Rph gave TYLENOL PM when patient came to store. 1-4 Patient said site went from purple to black and blue with pain, red circle in middle.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: 12-28 - patient complains of burning hot red, sensitive to touch. 12-29 - Rph gave TYLENOL PM when patient came to store. 1-4 Patient said site went from purple to black and blue with pain, red circle in middle.
Age: 59.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient received Menactra 12-31-2015 in afternoon, patient returned to pharmacy 5 days later (1-5-2016) and had red injection site reaction on left arm. It is warm to touch, she saw her personal physician who advised her to use hyrdocortisone cream on it. Questioned patient, no rash anywhere else on body and no anaphylactic reaction either.
Age: 34.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood test normal, Computerised tomogram normal, Headache, Lumbar puncture normal, Muscular weakness
Clinical narrative: Patient describes gradual onset of bilat LE weakness and "sore muscle pain" that progressed into bilat UE. These symptoms started axially and progressed into the feet and then hands. He also developed frontal HAs. He denies that there was any difficulty with breathing or swallowing. There also was no proceeding symptoms C/W viral or bacterial infection. He went to the ER for care and had a full W/U to include multiple spinal taps, blood work, and CT - all of which were non-diagnostic. He was sent home with medication for symptomatic relief. The symptoms slowly resolved over the course of two weeks. He now denies any residual symptoms and has a normal physical examination.