chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Muscle abscess, Wound, X-ray
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4-year-old female patient with obesity and esotropia of left eye. The patient was born prematurely (in 36 week of pregnancy) and spent a couple of weeks in neonatal intensive care unit (NICU). The patient had no concomitant medications, drug reactions, or allergies. On 27-FEB-2017, the patient was vaccinated with a dose of PROQUAD injection (RHA; lot # M037011, expiration date: 21-FEB-2018; dose and route of administration were not reported) and a dose of KINRIX (dose, route of administration, lot# and expiration date were not provided). On 28-FEB-2017, the patient developed redness and swelling at the injection site on her leg (unspecified). On 28-FEB-2017, the patient was taken to the hospital due to those events, but the reporter stated that nothing was done there. On 01-MAR-2017, the patient's symptoms got worse. On the same day, the patient was admitted to the hospital due to abscess on her leg (onset date was estimated to an unspecified date in approximately 2017). On an unspecified date approximately in March 2017, the patient had an unspecified x-ray performed, which revealed possible muscle involvement (onset date was estimated to an unspecified date in approximately 2017). Additionally, unspecified laboratory tests were performed (date and results were not provided). On an unspecified date in March 2017, the patient had a surgery to drain the abscess. The patient was treated with unspecified antibiotics. The nurse stated, the patient's wound would be left open and a "wound back" would be placed. The patient was going to be discharged on an unspecified date with home healthcare. At the time of the report, the patient was recovering from all adverse events. The relatedness between all adverse events and PROQUAD and KINRIX was not provided. The events were considered as significantly disabling by the reporting nurse. Upon internal review, the adverse events of abscess on the patient's leg and muscle abscess were considered to be medically significant. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Allergy to vaccine, Dyspnoea, Erythema, Headache, Injection site erythema
Clinical narrative: Initially, moderate pain at injection site, redness, warm to the touch, swelling in upper arm (measuring 3 inches in diameter). On 2/16/17, experienced tingling in left hand, difficulty breathing at night, headache, mild fever, 2/17/17: welt at injection site down to 2 inches in diameter, became itchy. Within a few days, hives appeared on inner thighs. 3/1/17: experienced excessive thirst, hives getting worst & spreading to belly, face, ears became red & swollen, ringing in ears, stiff neck, redness on buttock.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Initially, moderate pain at injection site, redness, warm to the touch, swelling in upper arm (measuring 3 inches in diameter). On 2/16/17, experienced tingling in left hand, difficulty breathing at night, headache, mild fever, 2/17/17: welt at injection site down to 2 inches in diameter, became itchy. Within a few days, hives appeared on inner thighs. 3/1/17: experienced excessive thirst, hives getting worst & spreading to belly, face, ears became red & swollen, ringing in ears, stiff neck, redness on buttock.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Paraesthesia, Pyrexia, Swelling, Thirst
Clinical narrative: Initially, moderate pain at injection site, redness, warm to the touch, swelling in upper arm (measuring 3 inches in diameter). On 2/16/17, experienced tingling in left hand, difficulty breathing at night, headache, mild fever, 2/17/17: welt at injection site down to 2 inches in diameter, became itchy. Within a few days, hives appeared on inner thighs. 3/1/17: experienced excessive thirst, hives getting worst & spreading to belly, face, ears became red & swollen, ringing in ears, stiff neck, redness on buttock.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Tinnitus, Urticaria
Clinical narrative: Initially, moderate pain at injection site, redness, warm to the touch, swelling in upper arm (measuring 3 inches in diameter). On 2/16/17, experienced tingling in left hand, difficulty breathing at night, headache, mild fever, 2/17/17: welt at injection site down to 2 inches in diameter, became itchy. Within a few days, hives appeared on inner thighs. 3/1/17: experienced excessive thirst, hives getting worst & spreading to belly, face, ears became red & swollen, ringing in ears, stiff neck, redness on buttock.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 21-FEB-2017, the patient was inadvertently vaccinated with a dose of PROQUAD and a dose of included VARIVAX both vaccines subcutaneously, (dose, anatomical location, lot number and expiration date were not reported) for prophylaxis. No adverse effects reported. Additional information is not expected because there was no consent for follow-up.
Sex: U
Vaccine: HPV4
Symptoms: Infertility
Clinical narrative: This spontaneous report was received from a physician who was informed by another physician via a company representative concerning to 21 year old patient of an unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unspecified date, the patient was vaccinated with a dose of GARDASIL for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported). It was reported that on an unknown date, the patient became "sterile" (Infertility) on an unspecified time after receiving the vaccine. The field representative stated that the physician may have learned of that event from reading an unspecified journal. There was no product quality complaint involved. The outcome of the event infertility and the causal relationship between the event and GARDASIL were not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 15-FEB-2017, the patient was administered with an expired dose of M-M-R II (strength, dose, frequency and route of administration were not provided) (lot # L003858 with expiration date of 05-FEB-2017) for prophylaxis. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 48.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 48 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-FEB-2017 the patient was vaccinated with a dose of ZOSTAVAX VIAL 19400 PFU subcutaneous injection (lot # M035693, expiration date 07-NOV-2017, dose and site of administration were not reported) subcutaneously for prophylaxis. This was outside of the prescribing information recommendation (inappropriate schedule of drug administration). No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information is not expected because there is no consent to contact the reporter.
Sex: M
Vaccine: PPV
Symptoms: Back pain
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a male patient of an unknown age with no drug reactions or allergies. There was no information about the patient's pertinent medical history. The patient's concurrent conditions included hypertension and hyperlipidemia. The patient's concomitant therapies included losartan potassium (manufacturer unknown), fenofibrate, and bisoprolol fumarate (+) hydrochlorothiazide. On 23-FEB-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot number: M018766, expiration date: 15-OCT-2017 (strength, dose, frequency, route, and anatomical location were not reported) and since the same date, the patient had a complaint of lower back pain. The patient did not undergo any laboratory tests or diagnostic procedure, however, he treated himself with ADVIL. It was reported that the patient sought medical attention but it was unspecified of which type. At the reporting time, the patient did not recover from the event of back pain. The causal relationship between the event of back pain and the therapy with PNEUMOVAX 23 was not provided. The reporter considered the event of back pain to be a disabling event. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Information about pertinent medical history, concomitant medication and concurrent condition was not provided. On 24-FEB-2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot# M041686, expiration date: 20-MAY-2018, dose and route unknown) for prophylaxis. The doses of vaccine were improperly stored at the temperature above 46 Fahrenheit (F) and below 77 F for 45 minutes. Data logger was involved. No previous temperature excursion was involved. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 28-FEB-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 (dose and frequency: 0.5 ml, once; lot # L024132, expiry date: 21-JAN-2017) intramuscularly for prophylaxis. No adverse effects were reported. 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 practitioner referring to 4 unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, each patient was vaccinated with a dose of improperly stored VARIVAX (dose and route were unknown; lot # M003440, expiry date: 20-JAN-2018). Data logger was involved. The doses of vaccine were improperly stored at the temperature above 14 Fahrenheit (F) but below 46 F for 9 months. There was no previous temperature excursion. No adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information was received on 02-MAR-2017 from a registered nurse regarding "three to four" patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. The registered nurse reported he had given "thousands" of ZOSTAVAX (lot numbers and expirations unknown) subcutaneous for prophylaxis on unknown dates to unspecified patients. On unknown dates, three to four very mild cases of rash were reported to him after vaccination.  The outcome of rash is unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In June 2016, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (route, lot # and expiration date were not reported). On 07-MAR-2017, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX for prophylaxis (route, lot # and expiration date were not reported). It was stated that the health worker was unaware that the patient was already administered the ZOSTAVAX. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A spontaneous report has been received from Physician via medical representative concerning a patient of unknown gender. Patient's relevant history, concurrent diseases and concomitant drugs were not provided. It was reported that child was administered nasal FLUMIST (intranasal) for flu vaccine during 2015 and developed A strain flu (Preferred Term: Influenza). FLUMIST was continued. The outcome of the event of flu was unknown. The company physician assessed the event of flu to be non serious. Corrected Report 10-Mar-2017: Trade name corrected for FLUMIST from FLUMIST to FLUMIST QUADRIVALENT. Key ingredient corrected from FLUMIT to Q/LAIV. Additional reporter added. Patient age group added as child.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus generalised, Rash macular
Clinical narrative: This is a spontaneous report from a contactable medical assistant calling on behalf of the physician. A 81-year-old female patient received on 07Mar2017, PREVNAR 13 (R33239, exp.date 31Mar2018, NDC number: 0005-1971-01) for immunization via unspecified route on the left deltoid. Medical history included breast cancer, colorectal cancer and hypertension. On the same date the patient experienced macular rash within 15-20 minutes of receiving injection, she was itchy all over. The patient received as treatment Depo-Medrol.  The outcome of the event was unknown.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Influenza, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer on 27-Feb-2017. This case involves a 57 years old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu Shot) and LYRICA (dose, dose in series, batch number, expiry date, site, route of administration were not reported for both) on an unknown date. Medical history was reported as arthritis, Surgery, Gastritis (2015). It was also reported that vomiting, diarrhea and fever was there in Dec-2015. Concomitant medications were not reported. On an unknown date of Oct-2016, following the vaccination, the patient experienced flu, fever 100 degrees, vomiting, and diarrhea. On an unknown date following vaccination, patient could not eat much, did not have an appetite and felt very tired and worn out. It was reported patient was previously vaccinated with INFLUENZA VACCINE in Dec-2015. Laboratory investigations and corrective treatment were not reported. The outcome of the event flu and vomiting was reported as recovered on an unknown date. Outcome of the event tiredness reported as not recovered. Outcome of the event fever and diarrhea reported as recovering. Outcome of the event appetite absent was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Vomiting
Clinical narrative: Initial unsolicited report received from a consumer on 27-Feb-2017. This case involves a 57 years old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu Shot) and LYRICA (dose, dose in series, batch number, expiry date, site, route of administration were not reported for both) on an unknown date. Medical history was reported as arthritis, Surgery, Gastritis (2015). It was also reported that vomiting, diarrhea and fever was there in Dec-2015. Concomitant medications were not reported. On an unknown date of Oct-2016, following the vaccination, the patient experienced flu, fever 100 degrees, vomiting, and diarrhea. On an unknown date following vaccination, patient could not eat much, did not have an appetite and felt very tired and worn out. It was reported patient was previously vaccinated with INFLUENZA VACCINE in Dec-2015. Laboratory investigations and corrective treatment were not reported. The outcome of the event flu and vomiting was reported as recovered on an unknown date. Outcome of the event tiredness reported as not recovered. Outcome of the event fever and diarrhea reported as recovering. Outcome of the event appetite absent was not reported. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Allergy to vaccine, Pyrexia, Viral upper respiratory tract infection
Clinical narrative: Initial unsolicited report received from a physician on 02-MAR-2017. This case involves a 68 years old female patient who was vaccinated with a dose on ADACEL (batch number, expiry date, dose, dose in series and route were not reported) in an unknown site on an unknown date. Patient's medical history and concomitant medications were reported as unknown. On an unknown date, following the vaccination, the patient developed Adacel allergy as cold symptom and fever. The patients Lab data and corrective treatment were not reported. The event outcome was not reported. List of documents held by sender: none.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unspecified age and gender. There was no information regarding the patient's medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On 10-OCT-2016, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, (anatomical location, dose, lot number, and expiration date were not provided), for prophylaxis. Subsequently, on 08-FEB-2017, the patient was vaccinated with other dose of ZOSTAVAX, subcutaneously, (anatomical location, dose, lot number, and expiration date were not provided), dose and frequency reported as "single dose bothe times", for prophylaxis. No product quality complaint was involved. Additional information is not expected as there was no consent to contact the physician.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Spinal anaesthesia
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 77 year old male patient. The patient did not have any concurrent conditions, pertinent medical history or drug reactions or allergies. On 04-FEB-2013, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (lot number, expiry date and dose were not reported) for prophylaxis. Concomitant therapies included aspirin (manufacturer unknown), esomeprazole sodium (NEXIUM), omega-3 acids, vitamins (unspecified), albuterol sulfate (VENTOLIN), simvastatin (manufacturer unknown), amitriptyline hydrochloride (manufacturer unknown), metformin, lisinopril (manufacturer unknown) and hydrochlorothiazide. On 02-DEC-2016, the patient sought medical attention and was diagnosed with shingles (herpes zoster.) Later, on 06-FEB-2017, the patient was diagnosed with post herpetic neuralgia.  In addition, it was reported that the patient was scheduled to see an unspecified anesthesiologist in March 2017 to receive an "spinal pain block", for an unspecified reason (adverse event.) It was also stated that the patient received an unspecified treatment for the reported events. No product quality complaint (PQC) was involved. At the reporting time, the outcome the events was reported as not recovered. The reporter did not provide a causality assessment between the events and the ZOSTAVAX. Additional information is not expected, because the reporting physician did not allow further follow up contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-FEB-2017, the patient was vaccinated with an improperly stored dose of GARDASIL lot #M037770 and expiration date 27-FEB-2017 (strength, route of administration, anatomical location and dose were unknown), which temperature excursion was more than 46 degrees Fahrenheit (8 degrees Celsius) but less than 77 degrees Fahrenheit (25 degrees Celsius) for 20 hours 25 minutes. Temperature was logged with a data logger, and there were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Herpes zoster, Herpes zoster oticus, Pruritus
Clinical narrative: This spontaneous report was received from an 82-year-old female patient reporting on herself. The patient's concurrent conditions included Parkinson's disease which was treated with unspecified medication for that medical condition as concomitant therapies. There was no information regarding the patient's pertinent medical history and drug reactions or allergies. On an unspecified date, also reported as "4 years ago or more", the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (SC) (strength, dose, frequency, anatomical location, lot number, and expiration date were not reported), for prophylaxis reported as for prevention of shingles. On 24-FEB-2017, the patient felt like she had an earache along with itching. Subsequently, on 27-FEB-2017, the patient sought medical attention through a visit to a physician who diagnosed her with shingles on the ear and prescribed valacyclovir hydrochloride as treatment. The patient also reported that the Herpes zoster oticus had spread to her jaw. At the time of this report, the patient had not recovered from the event of Herpes zoster oticus. The causal relationship between the adverse event and the therapy with ZOSTAVAX was not provided. No product quality complaint was involved. Upon internal review, the event of Herpes zoster oticus was considered to be medically significant. Additional information is not expected as there was no information to contact the physician.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 22-FEB-2017, the patient was vaccinated with an improperly store dose of VARIVAX injection, lot # M033214 with expiry date 13-JUL-2018 (exact dose and route of administration were not reported). The dose was exposed to the temperature higher than -10 degrees Celsius but lower than 8 degrees Celsius for 1 hour and 3 minutes. There was no previous temperature excursion. Digital data logger was involved. No symptoms were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 02-MAR-2017 from a licensed practical nurse regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB lot # M026309 expiration 11-NOV-2018, 10/1.0 mcrg/ml intramuscular for prophylaxis which was improperly stored. The vaccine was stored at a temperature >46 degrees F but < 76 degrees F for 66 hours. There was no previous temperature excursion. The call was made due to a data logger. No adverse effects were reported. No further information was reported.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse who is also an office manager, via company representative, regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, or concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an expired dose of PNEUMOVAX23 (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. No adverse effected were reported. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, or concomitant therapies were not reported. On 07-MAR-2017, the patient was vaccinated with the first dose of an expired ROTATEQ orally (strength and dose were not reported) (lot number; M002252; expiration date: 28-FEB-2017) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse referring to a 43 patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On an unknown date, the patients were vaccinated with an improperly stored doses of VARIVAX lot # M037008 with expiration date of 25-AUG-2017 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of >14 degrees Fahrenheit but <46 degrees Fahrenheit for 116 hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Dizziness
Clinical narrative: After 5 minutes of receiving her shot client stated "her stomach was hurting". I asked her if she needed to go to the bathroom and she said yes. I accompanied her to the restroom and she said she got really dizzy and lightheaded. I had her lower her head onto her knees, got her a wet towel from the sink. After the episode passed I accompanied her along with her mother to the exam room where she laid down. I elevated her feet and placed another cloth on her head and neck. Her B/P at that time was 87/56. Approx. 5 minutes later her B\P remained the same. At 9:10a she felt well enough to sit up on the table. I retook her B/P and it was 101/80. She had some fresh water and was ready to leave. I accompanied her to the waiting room with her mom and sister where they were getting a release for school. I called the clients mom at 10A and mom said she was fine, watching TV on the couch.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hemiparesis, Influenza like illness, Laboratory test abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: At time of vaccine patient had pox formation on bridge of nose fever and flu like illness with dizzy feeling. Approx. 2 months later she developed tinnitus and vertigo which worsened to requiring hospitalization. She had a VNG which showed unilateral weakness on the right consistent with a peripheral nerve lesion. I am not sure related to ZOSTAVAX but wanted to make sure.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral nerve lesion, Pyrexia, Rash pustular, Tinnitus, Vertigo
Clinical narrative: At time of vaccine patient had pox formation on bridge of nose fever and flu like illness with dizzy feeling. Approx. 2 months later she developed tinnitus and vertigo which worsened to requiring hospitalization. She had a VNG which showed unilateral weakness on the right consistent with a peripheral nerve lesion. I am not sure related to ZOSTAVAX but wanted to make sure.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported to the pharmacy and informed me that she experienced a rash from the PNEUMOVAX 23 shot she received on Tuesday.  She said she started experiencing swelling and redness around the injection site, which was also itchy and painful.  Below the injection site she noticed a rash wrapping around her arm.  She went to her physician's office on Wednesday (3/9) to have them examine it and they felt it was an allergic reaction.  She has been taking Advil to help with the pain and swelling, while alternating with cold and heat packs on the rash area per the physician's advice.  She came into the pharmacy on Friday (3/10) to inform us about the reaction.  I examined her arm and the swelling and redness has subsided, but there was still some evidence of a rash wrapping around her arm.  I advised her to continue the Advil and the use of cold packs.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Patient reported to the pharmacy and informed me that she experienced a rash from the PNEUMOVAX 23 shot she received on Tuesday.  She said she started experiencing swelling and redness around the injection site, which was also itchy and painful.  Below the injection site she noticed a rash wrapping around her arm.  She went to her physician's office on Wednesday (3/9) to have them examine it and they felt it was an allergic reaction.  She has been taking Advil to help with the pain and swelling, while alternating with cold and heat packs on the rash area per the physician's advice.  She came into the pharmacy on Friday (3/10) to inform us about the reaction.  I examined her arm and the swelling and redness has subsided, but there was still some evidence of a rash wrapping around her arm.  I advised her to continue the Advil and the use of cold packs.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Dyskinesia, Electroencephalogram, Insomnia, Irritability, Laboratory test
Clinical narrative: Extreme irritability, thrashing, insomnia, possible seizure activity for 72 hours post vaccine.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, fever, achy muscles, cough, fatigue.  Symptoms continued several days until Doctor prescribed a course of Amoxicillin on 3/8.  Today, 3/10, symptoms mainly gone.  Still have a slight fever and cough.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Mild rash, a couple of bumps on the back, a couple on the legs.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Petechiae, Pruritus, Skin lesion, Viral infection
Clinical narrative: Pimple like bumps started on lower front part of legs. Itchy, and spread.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner referring to a 17 year old patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 03-FEB-2017, the patient was vaccinated with RECOMBIVAX HB intramuscularly (strength, dose number, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. It was reported that the patient received an adult dose of RECOMBIVAX HB, however no known adverse effects reported. Additional information is not expected, since no consent to contact the reporter was provided.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G abnormal, Injection site discolouration, Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report was received from a physician referring to a 1 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-MAR-2013, the patient received a dose of VARIVAX lot number reported as H014073 (dose, route of administration and expiration date were not provided) for prophylaxis. On an unspecified date in March 2013, reported as within 24 hours after vaccination, the patient developed a black and blue area around the injection site and 1 to 2 days later, the patient had a red bumpy rash from his shoulder to wrist on the side of the injection. On an unknown date, the patient was seen by another physician and since the patient was afebrile no treatment was given for the adverse events. The patient did not experience significant disability nor incapacity, life threatening nor intervention to prevent serious criteria, he was not hospitalized. It was unknown by the reporter whether there was an overdose. The patient did not die. On 14-FEB-2017, the patient had a Varicella immunoglobulin G (IgG) drawn and the results showed no immunity (blood immunoglobulin G abnormal). On an unknown date, the patient took weeks to get better and was recovered from injection site rash and injection site bruising by the reporting time. The outcome of blood immunoglobulin G abnormal was unknown. The causal relationship between the events and VARIVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist referring to an adult female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, reported as 20 years ago, the patient received the first, second and third doses of RECOMBIVAX HB (route of administration, lot numbers and expiration dates for all doses were not provided) for prophylaxis. On 15-FEB-2017, the patient was tested for anti-HB serologic response titers and did not show a detectable anti-HB response (hepatitis b surface antibody negative). It was unknown whether the patient sought medical attention, if a treatment was given for the adverse event, if she had intervention to prevent serious criteria, if she experienced life threatening, significant disability or incapacity, cancer, overdose or hospitalization prolonged. The patient did not die. At the time of the report, the outcome of hepatitis b surface antibody negative was unknown. The causal relationship between hepatitis b surface antibody negative and RECOMBIVAX HB was not reported. Additional information is not expected because there was no consent to contact the reporter.
Age: 84.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist technician referring to an 84 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-FEB-2017, the patient received an expired dose of ZOSTAVAX subcutaneously, lot # K019388, expiration date 20-JAN-2016 for prophylaxis. No adverse effects were reported. No further details were provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: This spontaneous report was received from an 84 year old male patient referring to himself. The patient's concurrent conditions included Lou Gehrig's disease. The patient's concomitant therapies included TOPROL, AVODART, FLOMAX and riluzole. The patient's historical conditions were not provided. He had no drug reactions/allergies. Approximately in 2010 (also reported as 6 or 7 years ago), the patient was vaccinated with ZOSTAVAX refrigerated vial 19400 plaque-forming unit (PFU) to prevent shingles (dose, route of administration, lot number and expiration date were not reported). On approximately 08-FEB-2017 (reported as about 2 weeks ago), the patient developed a mild case of shingles after receiving the ZOSTAVAX from the physician. The patient reported that he developed an itchy rash on his chest. He received medical attention for shingles at the clinic (without hospitalization), and unspecified treatment was given for the event. Laboratory test were not performed. The outcome of the event was reported as recovering. The causal relationship between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The medical assistance reported that on an unknown date, the patient was vaccinated with one dose of pediatric RECOMBIVAX HB (dose, route, lot number and expiration date were not reported)  and one dose of pediatric VAQTA (dose, route, lot number and expiration date were not reported), both for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning an unspecified number of patients of unknown age and genders. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients might have received improperly stored doses of VARIVAX (lot number M035142, expiration date 03-AUG-2018, dose and route were not reported) for prophylaxis. The temperature exposure was from 14°F to 46°F for 3.5 hours (210 minutes). A data logger was involved and there was no previous temperature excursion. No adverse effects were reported. A product quality complaint was not involved. This is one of two cases reported from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA009130.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine professional and referred to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 01-FEB-2017 to 28-FEB-2017, those patients were vaccinated with improperly stored doses of VARIVAX lot # M037008, expiration date: 25-AUG-2018, for prophylaxis (dose, route of administration were not reported). The time frame for the improper storage amounted 120 hours in the temperature of 70 degrees Fahrenheit. No previous temperature excursion was reported. It was not a case of a data logger. No adverse effects were reported. The product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # L015460, expiration date: 20-JUL-2017, lot# L023936, expiration date: 15-MAR-2017 (dose and route of administration were not reported). The temperature excursion ranged between 32 and 36 degrees Fahrenheit and lasted 72 hours. There was no previous temperature excursion. Digital data logger was not used. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005126: US-009507513-1703USA005127: US-009507513-1703USA005128: US-009507513-1703USA005129.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a sales representative of another company refers to a group of unspecified nurses of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (dose, frequency, route and site of administration, lot # and expiry date were not reported) for prophylaxis. On an unknown date, the nurses attended a wellness event at their unspecified employer and were told that they would need boosters of RECOMBIVAX HB as a result of their antibody levels were not at therapeutic range. The outcome of the event was unknown. The relatedness between the event and the suspect therapy was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody positive, Mumps antibody test negative, Rubella antibody positive
Clinical narrative: This spontaneous report was received from other health professional concerning to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On a unspecified dates, the patient, was vaccinated with two doses of M-M-R II for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported). The reported stated that to the unspecified patient, on an unspecified date, a serological testing was performed and the results revealed: negative titer for mumps and positive titer for measles and rubella. The outcome of the event mumps antibody test negative was unknown and the causal relationship between the event and the M-M-R II was not reported. 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 nurse and refers to a multiple unknown patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On approximately 27-FEB-2017, reported also as unknown dates since 27-FEB-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# reported as M031553 with an expiration date 19-MAR-2018 for prophylaxis (dose was not reported). There was no adverse effect reported. Administered doses of ROTATEQ experienced temperature excursion from 0 to 2 degrees Celsius for 1 hour and 26 minutes. A digital data logger was involved. There was no previous temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA005123: US-009507513-1703USA005121: US-009507513-1703USA005122:
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 03-MAR-2017, the patient was vaccinated with an expired dose of GARDASIL injection, lot # K006191 with expiry date 02-FEB-2017, 0.5 ml intramuscularly. It was unknown which dose in the series that dose had been. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products
Clinical narrative: Information was received on 02-MAR-2017 from a registered nurse regarding a patient (reported as child- age and gender not provided). Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates "the child" received 2 doses of GARDASIL (dose not specified) and on an unspecified date the child received GARDASIL 9 for the third dose. The nurse wanted to know if they needed to start the 3 dose cycle over with GARDASIL 9 and if the 2 doses of GARDASIL were null and void. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9, MMR, PPV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 03-MAR-2017 from a registered nurse regarding multiple patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On multiple unknown dates, multiple unknown patients were vaccinated with doses of ROTATEQ (lot number and expiration unknown) oral GARDASIL 9 (lot number and expiration unknown) intramuscular, M-M-R II (lot number and expiration unknown) subcutaneous and PNEUMOVAX23 (lot number, expiration and route unknown) for prophylaxis which were improperly stored. The vaccines were stored at temperatures > 45 degrees F but < 77 degrees F for 10.5 hours and at temperatures between 32F and 36F for 2.6 hours. No previous temperature excursions were noted. No adverse effects were noted. No further information was provided. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Discomfort, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal discomfort
Clinical narrative: Information has been received via facility from a 55 year old female nurse referring to herself with asthma, sinus infection and migraine. The patient's medical history included separated shoulder. The patient received a flu shot and a tetanus shot in the past. Concomitant therapies included baclofen for migraine and unknown medications for asthma. On 03-MAR-2017 at about 16:30, the patient was vaccinated with PNEUMOVAX23, one dose (lot # and expiration date unknown), intramuscularly in her upper left deltoid one time for prophylaxis. On the same day, since receiving the vaccine, the patient was experiencing muscle pain that was spreading to her shoulder, pectoral muscle in her chest, muscles in her lower neck, the front and back of her rhomboid muscle from her shoulder to her spine. She also had pain in her deltoid and armpit. The pain was so severe she could not abduct or lift her arm and she felt like she had a separated shoulder or a sprained shoulder. She reported she could not lift anything or move her arm to the point that she could not reach behind herself to put on a shirt or bra. She also was experiencing severe pain under her collar bone. The pain was significant enough to cause her to need to brace her arm against her body. She could not get comfortable or sit down. The pain was spreading. Relevant laboratory data for the events was unknown. As of the reporting time, the patient no longer received PNEUMOVAX23 and the events persisted (not resolved). The causality between and PNEUMOVAX23 was not provided. The reporter considered the events to be medically significant. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA002496.