chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Excessive swelling, redness, warm to the touch, itching. All at the injection site. Treatments tried: OTC hydrocortisone 1% cream with no relief.
Age: 0.19
Sex: M
Vaccine: 6VAX-F, RVX
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Head to toe body rash/ hives (including palms and soles of feet), temperature of 101.8 when first checked.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site reaction, Nausea, Rash erythematous, Throat irritation
Clinical narrative: After several hours a bright red rash developed covering the entire right upper arm. She then reports feeling short of breath and itching throat with nausea and vomiting. She was advised to see a doctor but took at home breathing treatments instead. All symptoms have resolved.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: After several hours a bright red rash developed covering the entire right upper arm. She then reports feeling short of breath and itching throat with nausea and vomiting. She was advised to see a doctor but took at home breathing treatments instead. All symptoms have resolved.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Aphagia, Arthritis, Epstein-Barr virus antibody negative, Fatigue
Clinical narrative: This spontaneous report as received from a consumer as part of a marketing research program refers to a 14 year old female patient who is her daughter. No pertinent medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with GARDASIL (dose not reported). No other concomitant therapies reported. Consumer stated that this vaccine was safe and effective which the consumer did not believe that it was. The consumer's child had become very sick (hospitalization) because of this vaccine and her life has been altered in a negative way because of this 'safe' vaccine. The patient experienced psoriatic arthritis (hospitalization) that was not present before she received the vaccine. The consumer reported that the healthy daughter spent 4 months laying in bed, barely able to eat because she suffered from severe fatigue (disability, hospitalization) (days after receiving her vaccine). The consumer stated that the child went from healthy and active to sleeping 22 hours a day (hospitalization), not able to eat (hospitalization) and having to withdraw from school. The consumer stated that after 3 hospital stays, months of testing and finally fighting with the physician that something was wrong (as they said no even with 4 negative Epstein-Barr virus (EBV) tests), she was referred to a rheumatologist who had seen causes like this a lot lately. The consumer further stated that the patient was now suffering from arthritis in her back which was not there at her last well check at the end of 2013. The consumer had blindly allowed the doctor to talk the consumer into allowing the child to receive this vaccine without researching it. If the consumer had known that there are high risks for this vaccine and the fact that people with a family history of autoimmune based disorders (lupus, thyroid, RA, psoriasis, etc) should not receive this vaccine because of the increased risk of developing an AI (Autoimmune) disorder that can alter the child's life forever. The consumer would speak out and let everyone know not to vaccinate their child with this GARDASIL or anything like it. The outcome of the events was unknown. The causality of the events was unspecified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersomnia, Malaise, Psoriatic arthropathy
Clinical narrative: This spontaneous report as received from a consumer as part of a marketing research program refers to a 14 year old female patient who is her daughter. No pertinent medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with GARDASIL (dose not reported). No other concomitant therapies reported. Consumer stated that this vaccine was safe and effective which the consumer did not believe that it was. The consumer's child had become very sick (hospitalization) because of this vaccine and her life has been altered in a negative way because of this 'safe' vaccine. The patient experienced psoriatic arthritis (hospitalization) that was not present before she received the vaccine. The consumer reported that the healthy daughter spent 4 months laying in bed, barely able to eat because she suffered from severe fatigue (disability, hospitalization) (days after receiving her vaccine). The consumer stated that the child went from healthy and active to sleeping 22 hours a day (hospitalization), not able to eat (hospitalization) and having to withdraw from school. The consumer stated that after 3 hospital stays, months of testing and finally fighting with the physician that something was wrong (as they said no even with 4 negative Epstein-Barr virus (EBV) tests), she was referred to a rheumatologist who had seen causes like this a lot lately. The consumer further stated that the patient was now suffering from arthritis in her back which was not there at her last well check at the end of 2013. The consumer had blindly allowed the doctor to talk the consumer into allowing the child to receive this vaccine without researching it. If the consumer had known that there are high risks for this vaccine and the fact that people with a family history of autoimmune based disorders (lupus, thyroid, RA, psoriasis, etc) should not receive this vaccine because of the increased risk of developing an AI (Autoimmune) disorder that can alter the child's life forever. The consumer would speak out and let everyone know not to vaccinate their child with this GARDASIL or anything like it. The outcome of the events was unknown. The causality of the events was unspecified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient complained of redness, swelling and achiness around the injection site.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Confusional state, Dysstasia, Unresponsive to stimuli
Clinical narrative: Patient was given SC ZOSTAVAX, appeared to be doing fine while sitting in waiting area for other prescriptions. After approximately 10 mins she came to pharmacy counter to pay for prescriptions. She suddenly became confused, then unable to talk or stand. With her son's help she was lowered into a chair. She remained unresponsive but with visible and audible breathing for several minutes. During this time, 911 was called and an ambulance was activated. Eventually, patient was slowly able to regain consciousness and begin talking. She denied any signs of allergic reaction such as itchiness, facial swelling, or difficulty breathing. At that point, the patient and he son requested that the 911 call and ambulance be canceled. The son was comfortable with bringing her to her doctor's office in his own car for her to be seen. Patient was helped out to her car. A follow up phone call to her home about a hour later found that she was doing okay with no recurrence of symptoms. She had discussed event with her doctor and made him aware.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ, MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: MENACTRA dose was inadvertently used as diluent for MENVEO dose. No symptoms or adverse reaction noted.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pt states that after receiving flu shot she has pain in her left arm. NKDA. Cannot lift arm above/behind head. Pt. states pain when pulling and lifting items.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness postural, Muscular weakness, Myalgia
Clinical narrative: Pt is still experiencing muscle aches/weakness and dizziness upon standing shortly after and at least 5 days after vaccines. Going to doctors.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Local swelling, Skin warm
Clinical narrative: Patient developed swollen arm. NP at healthcare clinic called said arm swollen, treated as cellulitis, hot to the touch. Pt reported no fever.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Headache shortly after vaccine was administered. Went away after 3 hours.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site rash, Injection site reaction
Clinical narrative: Patient displays a reaction to the site of injection. The reaction consists of red rash, bruising in the upper arm. No fever.
Age: 1.51
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: 1st HPV - red hot itchy arm (approx 5 cm) lasting 10 d. Started the following am. 2nd HPV - red hot, itchy arm approx 15 cm lasting 0+ days. No fever, SOB.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site discolouration, Pain
Clinical narrative: Pt reports to have to turned black and blue at injection site immediately after vaccine administration. Pt feels sore and achy since the vaccine has been administered. She will be calling her doctor.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pt's husbands claims she had "excruciating pain" all over.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Malaise, Pain
Clinical narrative: Patient called pharmacy 9/22/14 at 1:55 PM stating that he believes he may have had a reaction to the FLUZONE HIGH DOSE vaccine -experiencing chills, aches, and temp of 101 within 24 hours of injection and feeling ill still as of call 9/22 -> patient referred to PCP for follow up.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: On 9-16-14 pt received High Dose flu vaccine (L) upper arm. Pt reports 9-17-14 she had raised red areas on (L) arm which cause itching. Appt. today for 6 mo. f/u and reported. A few red areas still evident. No treatment ordered.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Local swelling, Pain, Sleep disorder
Clinical narrative: Severe pain, unable to sleep on left side for 3 day. Allergic reaction, severe redness and swelling of most of left arm pt took prednisone for symptom relief and symptom tx.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Patient said she started itching all over a couple of hours after getting vaccine. She tried multiple BENADRYL and ended up using an EPI-PEN, was still taking BENADRYL the next day.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Headache, Injection site erythema, Pain in extremity
Clinical narrative: Pt got shot on 9-16 and on 9-17 started getting HA, chills, fever, her arm hurt, was red and really hot and the redness was traveling from injection site around inside of arm.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Pt got shot on 9-16 and on 9-17 started getting HA, chills, fever, her arm hurt, was red and really hot and the redness was traveling from injection site around inside of arm.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a 12 month old patient of unknown gender. The healthcare worker confirmed that ZOSTAVAX was mistakenly shipped to this office instead of VARIVAX (Merck). The patient was then inadvertently vaccinated with the first dose of ZOSTAVAX (dose, route not reported, lot # K007986, expiration date 03-SEP-2015) instead of VARIVAX (Merck), "within this past week", in approximately in September 2014. Concomitant medications were not provided. No adverse effects were reported. This is one of eight reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Patient found unresponsive on 9/22/14 by parents in his bed. 911 called, ACLS protocol initiated, however pt expired and pronounced dead in ED.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient can't move arm at shoulder level. Can't lift arm up over her head without pain. Will be seeing a neurologist on 9/24/14.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Patient had numbness around her lips and the left jaw.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Myalgia
Clinical narrative: Patient experiencing muscle pain in both legs from butt to ankle. Has a hard time walking.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Rash erythematous
Clinical narrative: Red sunburn type rash developed about 24 hours after GARDASIL injection. Patient seen by Dr on 9/22/14 Triamcinolone acetonide 40 mg IM given. Instructed to return to clinic if not improved within 2 days.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Adverse drug reaction, Injection site pain, Rash erythematous
Clinical narrative: Red sunburn type rash developed about 24 hours after GARDASIL injection. Patient seen by Dr on 9/22/14 Triamcinolone acetonide 40 mg IM given. Instructed to return to clinic if not improved within 2 days.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site swelling, Malaise, Pyrexia, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Erythema, warmth at vaccine site on (R) arm and associated surrounding erythema/swelling of (R) upper arm; fever, malaise.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site abscess, Injection site warmth, Rash erythematous
Clinical narrative: About 2.5-3" round, red rash at injection site. Warm to touch. Not raised.
Age: 57.0
Sex: U
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Numbness of left hand. Pain at site of injection.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Nodule
Clinical narrative: 9/22/14 at 11am shot received, 9/22/14 evening arm burning and red and knotted. 9/23/14 still red and burning at knot no longer.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Chills, aching, flu like symptoms, swollen, red and rash at injection site, inflamed, itching and sore to the touch.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Pain
Clinical narrative: Chills, aching, flu like symptoms, swollen, red and rash at injection site, inflamed, itching and sore to the touch.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Immediate post-injection reaction, Injection site pain, Nausea, Pain in extremity
Clinical narrative: Painful at time of injection - (Hasn't happened with previous flu vaccines). The next day she felt faint and almost passed out. It lasted about 15 min. splashed cold water on face and rested until feeling went away. Upper legs hurt and nausea. Severe pain.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a 12 month old patient of unknown gender. The healthcare worker confirmed that ZOSTAVAX was mistakenly shipped to this office instead of (Merck) VARIVAX. The patient was then inadvertently vaccinated with the ZOSTAVAX (dose, route not reported, lot # K007986, expiration date 03-SEP-2015) instead of (Merck) VARIVAX, "within this past week", in approximately in September 2014. Concomitant medications were not provided. No adverse effects were reported. This is one of eight reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a 12 month old patient of unknown gender. The healthcare worker confirmed that ZOSTAVAX was mistakenly shipped to this office instead of (Merck) VARIVAX. The patient was then inadvertently vaccinated with the first dose of ZOSTAVAX (dose, route not reported, lot # K007986, expiration date 03-SEP-2015) instead of (Merck) VARIVAX, "within this past week", in approximately in September 2014. Concomitant medications were not provided. No adverse effects were reported. This is one of eight reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old patient. On 05-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23, lot # J009827, expiration date 10-AUG-2014, dose and route not reported. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. In September 2014, reported as between 05-SEP-2014 through 11-SEP-2014, the patients were vaccinated with doses (unspecified in series) MMR II lot number J004204, expiration date 12-APR-2015, subcutaneously. No adverse effects were reported. Concomitant medications were not specified. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age. On unknown dates patients were vaccinated with ZOSTAVAX (dose, lot no. and route unknown). No concomitant medication was reported. The patients were inadvertently administered vaccine that had been improperly stored. No adverse effects were reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On unknown dates unknown number of patients were vaccinated with (Merck) VARIVAX (dose, lot no and route unknown). No concomitant medication was reported. The patients were inadvertently administered vaccine that had been improperly stored. No adverse effects were reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received form a medical assistant refers to unknown number of patients of unknown age. On unknown dates patients were vaccinated with PNEUMOVAX 23 (dose, lot no. and route unknown). No concomitant medication was reported. The patients were inadvertently administered vaccine that had been improperly stored. No adverse effects were reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age. On unknown dates patients were vaccinated with GARDASIL (dose, lot no. and route unknown). No concomitant medication was reported. The patients were inadvertently administered vaccine that had been improperly stored. No adverse effects were reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to patients of unknown age. On unknown dates unknown number of patients were vaccinated with MMR (manufacturer unknown) (dose, lot no. and route unknown). No concomitant medication was reported. The patients were inadvertently administered vaccine that had been improperly stored. No adverse effects were reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 04-SEP-2014 (also reported as two weeks ago) the patient was vaccinated with ZOSTAVAX (dosing regimen unknown). The reporter stated that on an unknown date he got an electric order for prednisone (manufacturer unknown) for the patient from physician's office. The reporter stated it was unknown if the patient had an adverse event. The outcome of the event was unknown. The causality of event was not reported. No product quality complaint was reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 08-SEP-2014 the patient was vaccinated with expired PNEUMOVAX 23 lot # J004080, 22-AUG-2014, intramuscular and no known adverse effects reported. No concomitant medications reported. The patient present status reported as no known adverse effects. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 72 year old female patient. The patient had sulfa and BIAXIN reaction/allergy. On unknown date in 2012 (reported as 2 years ago), the patient was vaccinated with ZOSTAVAX (dosage information unknown). No concomitant medication was reported. The nurse reported that patient experienced shingles on two occasions after the vaccination. The first occurrence was on an unknown date. The second occurrence was on 11-JUL-2014, when patient presented with vesicular outbreak on the left side of her face and ear. The outcome and causality of the events were unknown. The patient was treated with VALTREX and sought medical attention (saw nurse practitioner). A product quality complaint (PQC) was not involved. A voice message left for return call from nurse to give permission for VZVIP (Varicella Zoster virus) packet to be sent. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old female patient, with no pertinent medical history and no drug reactions or allergies, who was not pregnant. On 08-JUL-2014, the patient was vaccinated with a dose (dose number not reported) of GARDASIL lot number J009243, expiration date 23-APR-2016, 0.5 ml, intramuscularly as a routine vaccination. There were no concomitant medications. On 08-JUL-2014, the patient experienced bilateral leg pain after receiving GARDASIL. No treatment was given for the adverse event. There were no lab diagnostics studies performed. The patient did not seek medical attention. The outcome of bilateral leg pain was reported as recovered after about a week (on approximately 15-JUL-2014). The relatedness between the bilateral leg pain and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an adult (exact age not specified) patient of unknown gender. Medical history and drug reactions or allergies were not specified. On an unknown date, reported as a couple of years ago, the patient was vaccinated with the first dose of VARIVAX (dose, route and lot number were not reported). Concomitant medications were not specified. On 17-SEP-2014, reported as currently, the patient was at the office to received their second dose of VARIVAX (dose, route and lot number were not reported). No adverse effect was reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old patient of unknown gender with no pertinent medical history, drug reactions or allergies. On 15-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX lot number K003598, expiration date 13-MAR-2015. ZOSTAVAX administration was intramuscular versus subcutaneous, inadvertently. There were no concomitant medications. On 16-SEP-2014, the patient contacted pharmacy with complains of pain, swelling and redness at injection site (the exact onset date of the events was not specified). The patient sought medical attention via contacting the pharmacy. No treatment was given at the time of contact and the patient was planning to visit an unspecified family physician on 17-SEP-2014, also reported as today. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown ages and genders. On an unknown date unknown number of patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (lot number, expiration date, dose, frequency, route were not reported). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown ages and genders. On an unknown date unknown number of patients were vaccinated with a dose of improperly stored MMR II (lot number, expiration date, dose, frequency, route were not reported). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown ages and genders. On an unknown date unknown number of patients were vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot number, expiration date, dose, frequency, route were not reported). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown ages and genders. On an unknown date unknown number of patients were vaccinated with a dose of improperly stored GARDASIL (lot number, expiration date, dose, frequency, route were not reported). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 24 year old female patient. The patient's medical history included birth of her child (date not specified). In 1991, exact date not specified, the patient was vaccinated with the first dose of M-M-R II. On an unknown date, the patient received the second dose of M-M-R II. On 09-SEP-2014, the patient was vaccinated with the third dose of M-M-R II (HSA) lot number J004204, expiration date 12-APR-2015, 0.5 ml, subcutaneous in the left arm, which was improperly stored. No adverse effects were reported. Concomitant medications were not specified. Additional information is not expected because the reporter did not give consent for follow up.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to 4 patient of unknown age and gender. On 15-SEP-2014 the patients were vaccinated with MMR II (therapy type, dose, route, lot # and expiration date were not reported) that had been improperly stored. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 15-SEP-2014 the patient was vaccinated with a dose of VAQTA (dose, route, lot # and expiration date were not reported) that had been improperly stored. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to 2 patients of unknown age and gender. On 15-SEP-2014 the patients were vaccinated with RECOMBIVAX HB (therapy type, dose, route, lot # and expiration date were not reported) that had been improperly stored. No adverse effects were reported. No PQC (product quality complaint) was involved This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown age and unknown gender. No pertinent medical history, drug reactions or allergies were reported. Since 12-AUG-2014, improperly stored RECOMBIVAX HB was administered to an unknown number of patients (dose, dose number, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were noted. No concomitant therapies were reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient. The patient had no known pertinent medical history or drug reactions/allergies. On 10-SEP-2014, the patient was vaccinated with a dose of PNEUMOVAX 23, (route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. On 10-SEP-2014 by that evening, the patient stated that her arm was really sore. The pharmacist stated that the patient called the pharmacy on 12-SEP-2014 and reported that she had limitation of her arm movement. The pharmacist stated that the patient cannot move her arm above her elbow and her shoulder was immobile as well. The patient had not received any treatment for the events. No laboratory test has been performed. At the time of the report, the patient had not recovered from events and the relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The reporter stated that since 28-JUL-2014 an unspecified number of patients have been administered GARDASIL (dose, units, frequency, lot number were not reported) that was improperly stored. This excursion was supported. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old male patient. On 15-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J005071, expiry date: 19-JAN-2015, dose and route of administration was unknown). Concomitant therapies included HUMALOG, valacyclovir hydrochloride, LEVITRA, LANTUS, latanoprost and timolol maleate (manufacturer unknown). No pertinent medical history and drug allergies were reported. On 16-SEP-2014, the patient experienced swelling at the injection site that was warm to touch. No treatment was given for the event. No lab diagnostics studies were performed. The patient contacted the reporter and sought medical attention. The outcome of the events was reported as recovering/resolving. The causality was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The reporter stated that since 28-JUL-2014 an unspecified number of patients have been administered PEDVAXHIB (dose, units, route of administration, lot number were not reported) that was improperly stored. This excursion was supported. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The reporter stated that since 28-JUL-2014 an unspecified number of patients have been administered RECOMBIVAX HB dose, units, frequency, lot number were not reported that was improperly stored. This excursion was supported. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The reporter stated that since 28-JUL-2014 an unspecified number of patients have been administered VAQTA (dose, units, route of administration, lot number were not reported) that was improperly stored. This excursion was supported. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The reporter stated that since 28-JUL-2014 an unspecified number of patients have been administered ROTATEQ dose, units, frequency, lot number were not reported that was improperly stored. This excursion was supported. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practitioner nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored ROTATEQ, oral, (lot#, strength, dose and frequency unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown ages and genders. On unspecified dates in 2014, doses of PEDVAXHIB (lot# and expired date unspecified) and other vaccines were administered to unspecified patients (dose, frequency and route unspecified), after exposed to temperatures of 10 C degree for 37.5 hours/temperature excursions on 08-AUG-2014, 13-AUG-2014 and 28-AUG-2014. No adverse effect has been reported. This is of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to two patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX batch/lot number, expiration date not provided, 0.5 ml, subcutaneous, exposed to -14 degrees Celsius for 731 hours. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (dose, route of administration, indication, lot# and expiry date unspecified), that were improperly stored on an unspecified date. No concomitant medications were reported. The dose was administered according to the prescribing information. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to three patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with a dose of PEDVAXHIB injection (dose, route of administration, indication, lot# and expiry date unspecified), that were improperly stored on an unspecified date. No concomitant medications were reported. The doses were administered according to the prescribing information. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practitioner nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored M-M-R II, (lot#, strength, dose frequency and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to three patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with a dose of ROTATEQ injection, route of administration not reported, defaulted to oral (dose, indication, lot# and expiry date unspecified), that were improperly stored on an unspecified date. No concomitant medications were reported. The doses were administered according to the prescribing information. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with GARDASIL, 0.5 ml, intramuscular (lot # and expiration date were not provided). On an unknown date, GARDASIL was stored at 30F for 34 hours. Excursion was not supported. Medical assistant stated that several different lots and expiration dates were involved, but she did not have access to the information. On unknown dates, many patients had been administered the not supported GARDASIL but she had no patients' information to provide because her office had not pulled the records. No adverse effects had been noted by any patients. The patients did not seek medical attention. At the time of the report, the patients status was unknown. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse, via consumer reporting on male patients of unknown age, as part of a market research program. On an unknown date the patients were vaccinated with a dose of GARDASIL (dose, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse noticed a trend of large number of boys experiencing syncope under her care, also reported as she had experienced a huge increase of males with syncope. The nurse reported all patients had syncope never had it before GARDASIL but did after. Had never had large number of boys with syncope in the past. Only common factor with all boys was GARDASIL. At the time of the report the outcome was unknown. This is one of three reports from the same source (1409USA010733, 1409USA011219 and 1409USA009660). Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old male patient with no pertinent medical history and no drug reactions or allergies reported. On 19-SEP-2014 the patient was vaccinated with a dose of GARDASIL (route, dose, lot # and frequency not reported). No concomitant therapy was reported. On an unknown date in September 2014 the patient experienced redness at the injection site. No adverse symptoms were reported. There was no lab diagnostic studies performed. The outcome of redness at the injection site was reported as recovered/resolved (on an unknown date in September 2014). The patient sought medical attention. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a 12 month old patient of unknown gender. The healthcare worker confirmed that ZOSTAVAX was mistakenly shipped to this office instead of VARIVAX. The patient was then inadvertently vaccinated with the first dose of ZOSTAVAX (dose, route not reported, lot # K007986, expiration date 03-SEP-2015) instead of VARIVAX, "within this past week", in approximately in September 2014. Concomitant medications were not provided. No adverse effects were reported. This is one of eight reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a administrator, concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 15-SEP-2014, the patient was vaccinated with the second dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The administrator reported that an unspecified patient received dose one of GARDASIL on 09-APR-2008. The administrator reported that this patient received dose two of GARDASIL on 15-SEP-2014. No adverse effects reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a register nurse concerning an approximately 70 year old female patient (reported in her 70's). Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, expiration date and route were not reported) dose reported as 1 injection. Co-suspect and concomitant therapies were not reported. The register nurse reported that on an unknown date, the patient developed shingles along her hairline after being administered the ZOSTAVAX vaccine. At the time of the report the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician via a sales representative refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB (route, dose, lot # and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. On an unknown date, the physician reported that one of his patients, who completed RECOMBIVAX HB (cannot be ruled out), on an unspecified dates, had titer drawn and titer result was negative for Hepatitis B antibody. At the time of the report, the patient's outcome and the relatedness between the event and suspect therapy were unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practitioner nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patient were vaccinated with improperly stored PROQUAD (Merck), (lot#, strength, dose, fre4quency and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse refers to a female patient of unknown age. Medical history, concomitant medication and current conditions were not reported. On 26-OCT-2013, the patient was vaccinated with VARIVAX (dose, indication, Lot # and expiration date were not provided) in error, because the patient was indicated to receive ZOSTAVAX. The nurse states that the person who administered the dose of VARIVAX to the patient may have confused VARIVAX with ZOSTAVAX. The nurse reports "They refer to ZOSTAVAX as chickenpox because if a person has had chickenpox, he or she has chance of developing shingles." The medication error was identified on a routine office visit on an unknown date, on which the patient claimed she had received the shingles vaccine. The patient did not experience any adverse events. Additional information has been requested.