chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Oropharyngeal pain, Respiratory tract congestion, Streptococcus test negative
Clinical narrative: Chest congestion began, following next morning by acute sore throat & swollen gland in throat, coughing & coughing.  After 2 wk had strep culture (negative) & developed Shingles. Low temp. at & below 97 most of time, continues 3 wk later. Improving very slowly, too tired to do anything except rest.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Basedow's disease, Blood test abnormal, Cardiovascular evaluation, Heart rate increased
Clinical narrative: Over three year period following vaccine heart rate increased from approx. 70 bpm to approximately 100 bpm. By July, 2015 resting heart rate exceeded 120 bpm.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pruritus, Urticaria
Clinical narrative: Flu shot given 2-5-16, pt. complained of itchy skin, achey, headache and 1 hive of face during the weekend. Mom called 2-8-16 to report symptoms.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Noticed a diffuse rash/bruise below deltoid and runny to bicep. No inflame at injection site. No itchy/burning. Appeared approximately 24 hrs after injections. Pt. told to f/u w/MD. (R) rash grew and MD consultation called into office. No other symptoms reported.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left deltoid -localized redness and warm to the touch 24 hrs after vaccine. No treatment needed.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid; injection site red. Swelling, sore and warm to touch. No treatment.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid; slight swelling, discomfort and warm to the touch at injection site. No treatment.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Tenderness at injection site. Below the injection site, area was red and warm and itchy. PA recommended CLARITIN and hydrocortisone cream.
Age: 61.0
Sex: U
Vaccine: FLU3, VARZOS
Symptoms: Contusion
Clinical narrative: Bruising on each arm.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Musculoskeletal pain, Pain in extremity, Sleep disorder
Clinical narrative: Pt. received flu shot and for 4 or 5 days after shot pt had pain at inj. site and lasted until Dec. 11 when pain radiated down to elbow then hand and shoulder blade and hard to get up several times at night to ice that area.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left thigh at site of PEDIARIX immunization. Rx: BACTRIM x 7 days.
Age: 87.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bursitis, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from an 87 year old female patient regarding herself. The patient did not have any concurrent conditions, medical history and drug allergies. On an unknown date in October 2015 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscular. On an unknown date in 2015, two weeks after the injection, the patient experienced pain and swelling in both of her shoulders. The patient did not receive any treatment for the same. No laboratory tests were conducted. No product quality complaint was involved. The outcome of the events was not recovered/not resolved. The causality assessment was not provided. Additional information is not expected, no contact details were provided.
Age: 87.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Musculoskeletal pain, Swelling
Clinical narrative: This spontaneous report as received from an 87 year old female patient regarding herself. The patient did not have any concurrent conditions, medical history and drug allergies. On an unknown date in October 2015 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscular. On an unknown date in 2015, two weeks after the injection, the patient experienced pain and swelling in both of her shoulders. The patient did not receive any treatment for the same. No laboratory tests were conducted. No product quality complaint was involved. The outcome of the events was not recovered/not resolved. The causality assessment was not provided. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date: 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 29-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 [Lot# 011531, Expiry date: 07-JAN-2017] (strength, dose and route of administration were not reported) which was improperly stored at a temperature of 51 degree Fahrenheit for total 30 hours. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 03-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 03-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQc0 involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 05-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L0085744, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 03-DEC-2015, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) after being improperly stored (incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 22-JAN-2016, the patient was vaccinated with (Oka/Merck) VARIVAX (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (Temperature: 9.5 F, Time frame: 2 hours). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 22-JAN-2016, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) after being improperly stored (incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a nurse refers to a 19 year old female patient. No concurrent condition or medical history was reported. On an unknown date in 1996 or 1997, the patient was vaccinated with 3 dose series of RECOMBIVAX HB (dose and route of administration not provided). No concomitant therapy was reported. The patient had titers withdrawn on an unknown date and serological testing showed negative titers i.e. no immunity. The patient was given then 2 booster dose of RECOMBIVAX HB on 28-AUG-2015 and 02-DEC-2015. On an unknown date, recently, the patient had titers drawn again which also came back negative. The reporter inquires if the patient should receive another dose or another series of doses of RECOMBIVAX HB and if so when they should be administered to the patient. The outcome of the event was unknown. The reporter considered event to be related to suspect therapy. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 01-FEB-2016, the patient was vaccinated with improperly stored dose of ZOSTAVAX (temperature: 43 F, time frame: 44 days) (lot # L034736, exp. 01-FEB-2016, dose and route was not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from the same reporter link. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. 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 medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 07-DEC-2015, the patient was vaccinated with (Oka/Merck) VARIVAX (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure abnormal, Dizziness
Clinical narrative: This spontaneous report as received from a healthcare worker via field representative refers to a 15 year old female patient. The patient's pertinent medical history was none. Approximately in 2014 (reported as 2 years ago), the patient was vaccinated with GARDASIL 9 (lot # L016429; expiry date: 09-AUG-2017). Concomitant medications were none. On 03-FEB-2016, the patient felt light headed or dizzy. The patient's blood pressure was 98/40 (units not reported) and the patient was kept in the office until her blood pressure was normal. The patient sought medical attention and no treatment was provided for the events. The outcome of the events was recovered on an unspecified date in February 2016. The causality of the reported events was not 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-AUG-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX, lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. 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 health care worker regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 23-DEC-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot # L013188, expiration date 02-NOV-2017). There was no adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Eye pruritus, Pruritus, Tongue disorder
Clinical narrative: Patient did not report until following day. Itching eyes/face 20 min after vaccines. No respiratory problems. Tongue "felt heavy" but no trouble swallowing same evening, resolved next day.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: Pt received HPV9 on 12/8. C/o fever, sore arm and head ache the next day. HA lasted 3 wks, daily, throbbing and self-limited. Some dizziness and nausea no vomiting seen in office on 12/17. Normal neuro exam. No hx of headache in the past. Unsure if to give more HPV vaccine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chest discomfort, Chills, Decreased appetite, Diarrhoea
Clinical narrative: Chills, fever, upset stomach, loss of appetite, diarrhea, headache, "chest pressure"/shortness of breath, body felt heavy, extremely tired, big round red rash at injection site, lump at injection site treatment: BENADRYL, rest. Lasted 6 days.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Dyspnoea, Fatigue, Headache, Injection site erythema
Clinical narrative: Chills, fever, upset stomach, loss of appetite, diarrhea, headache, "chest pressure"/shortness of breath, body felt heavy, extremely tired, big round red rash at injection site, lump at injection site treatment: BENADRYL, rest. Lasted 6 days.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site rash, Pyrexia
Clinical narrative: Chills, fever, upset stomach, loss of appetite, diarrhea, headache, "chest pressure"/shortness of breath, body felt heavy, extremely tired, big round red rash at injection site, lump at injection site treatment: BENADRYL, rest. Lasted 6 days.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant referring to multiple unspecified patients. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On unspecified dates, the patients were administered RECOMBIVAX HB (L016427, Expiration Date 13-APR-2017; dose, frequency and route unspecified). The Hepatitis B Vaccine (RECOMBIVAX HB) had been exposed to temperature of 1 degree centigrade, coldest temperature. The total cumulative time was unspecified. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Muscular weakness, Myalgia, Pain, Pain in extremity
Clinical narrative: Received IM injection 10/28/15, then 11/18/15 pt informed pharmacist still had arm pain/weakness. Still sore but no nerve/joint pain. Said a little better - but feels her arm is weaker and generally hurts when moved/muscle pain. Pt still same Jan/Feb 2016. Will see diff MD.
Age: 5.0
Sex: F
Vaccine: HEP, HEPA, MMRV, MNQ, TDAP
Symptoms: Injection site vesicles
Clinical narrative: C/o fluid filled blister 1-2cm in diameter at injection site. Instructed to cover it, and take TYLENOL/Ibuprofen if necessary.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site pain, Muscular weakness, Pain
Clinical narrative: Patient reports being unusually tired x 2 days after vaccine. Reports pain initially at injection site that moves to various other areas on her body. Extreme weakness in upper extremities.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration dare 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a pharmacist, refers to about 200 patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The pharmacist stated that on an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L004754, expiration date: 10-NOV-2016 and lot # L016427, expiration date: 13-APR-2017, (dosage and route were not provided). Concomitant therapy was not reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4 C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date: 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse via a company representative referring to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with an expired dose of ZOSTAVAX (strength, dose, lot #, expiration date and frequency were not provided). Concomitant therapies were not provided. The registered nurse also reported that no adverse effects occurred. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Nodule
Clinical narrative: Knot on arm.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: 4" x 2" red rash. 4" x 7" swollen area. Both around shot location.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test, Oropharyngeal pain
Clinical narrative: Patient was taken to emergency room for pain in throat after receiving HPV vaccine. Per mother was given BENADRYL.
Age: 0.35
Sex: F
Vaccine: DTPIHI, HEP, HIBV, IPV, PNC13
Symptoms: Drooling, Eye swelling, Lethargy, Posture abnormal, Pyrexia
Clinical narrative: Fever, drooling, vomiting, lethargic couldn't hold her head up, swollen eyes.
Age: 0.35
Sex: F
Vaccine: DTPIHI, HEP, HIBV, IPV, PNC13
Symptoms: Vomiting
Clinical narrative: Fever, drooling, vomiting, lethargic couldn't hold her head up, swollen eyes.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There was no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Confusional state, Dizziness, Immediate post-injection reaction, Loss of consciousness, Nausea
Clinical narrative: Fainted after last of the three vaccines was given. Pt immediately reported she felt faint, I immediately laid her back on the table. There was a slight LOC, but upon MD coming in the room seconds later the patient had eyes open and confused as to what had happened. I had her on the table laying down until she was able to tolerate sitting up. Once able to do this the pt tolerated water and pretzels and was feeling better but still slightly nauseous. Ambulated to the car with mother and sister.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Fainted after last of the three vaccines was given. Pt immediately reported she felt faint, I immediately laid her back on the table. There was a slight LOC, but upon MD coming in the room seconds later the patient had eyes open and confused as to what had happened. I had her on the table laying down until she was able to tolerate sitting up. Once able to do this the pt tolerated water and pretzels and was feeling better but still slightly nauseous. Ambulated to the car with mother and sister.
Age: 13.0
Sex: M
Vaccine: FLUX, HEPA, HPV9, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 02-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (confirmed no GARDASIL) (lot # L016428, expiration date: 09-AUG-2017) (dose, route of administration and frequency were not reported). It was stated that the temperature and time frame were 27 deg F for 168 hours. Concomitant medications were not reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Fall, Lip injury, Syncope, Tooth fracture
Clinical narrative: Patient received Hep A and varicella vaccines approx. 2:30 pm. Within 20 min patient syncopized in the room and struck her mouth on something as she fell. Chipped two teeth with minor lac to lip.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: Patient c/o swelling, pain, itching and tenderness to upper extremity. Other physician office Dx with cellulitis.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 02-FEB-2016 the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # K009105 with expiration date of 21-JAN-2016, dose, strength and route unknown). The nurse stated the PNEUMOVAX 23 did not have any temperature excursions. No adverse symptoms reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: "Mentally fuzzy", body aches, arm pain, increased panic attacks, red, warm swollen at injection site, covering large portion of outer upper arm.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Panic attack
Clinical narrative: "Mentally fuzzy", body aches, arm pain, increased panic attacks, red, warm swollen at injection site, covering large portion of outer upper arm.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm
Clinical narrative: Warm, itchy, 203 inch circular hive.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Papilloma viral infection
Clinical narrative: This spontaneous report was received from a female patient of unknown age, reporting on herself. No medical history or concurrent conditions were reported. On an unknown date, approximately in 2012 reported as "three or four years ago", the patient was vaccinated with the first dose of GARDASIL via intramuscular (strength and lot number were not reported), the patient did not continue with the second and third dose. Concomitant medication was not reported. The patient reported that on unknown date, reported as "now" she was experiencing unspecified symptoms of genital warts and unspecified HPV diseases. The outcome of unspecified symptoms of genital warts and unspecified HPV diseases was unknown and the causality assessment was not provided. Additional information is not expected, since reporter details were not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-DEC-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot # L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant referring to multiple unspecified patients. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On unspecified dates, the patients were administered VAQTA (L022259, Expiration Date 06-APR-2017; dose, frequency and route unspecified). The Hepatitis A Vaccine, VAQTA had been exposed to temperature of 1 degree centigrade, coldest temperature. The total cumulative time was unspecified. The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to multiple unspecified patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant medications were not reported. On 05-FEB-2016, the patients were administered improperly stored doses, by a time frame of an hour and 30 minutes with a temperature of 57F, of RECOMBIVAX HB (Lot# L027733, expiration date: 13-AUG-2017; Lot# L044707, expiration date 06-OCT-2018). No adverse effect reported. There was no product quality complaint involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to multiple unspecified patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant medications were not reported. On 05-FEB-2016, the patients were administered improperly stored doses, by a time from of an hour and 30 minutes with a temperature of 57F, of VAQTA (Lot#, L034381, expiration date 21-DEC-2016; Lot# L030442, expiration date 19-DEC-2016; Lot# L014068, expiration date 02-NOV-2017). No adverse effect reported. There was no product quality complaint involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: MMR, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician referring to a 4 month old female patient. No concurrent or historical conditions were reported. On 24-NOV-2015, the patient was vaccinated with PNEUMOVAX 23 (lot # L012521, expiration date February 2017), 0.5 ml, intramuscular in the left thigh (Inappropriate schedule of vaccine administered) and on the same day the patient was also vaccinated with M-M-R II (Lot # K004948, expiration date 04-APR-2016), 0.5 ml, subcutaneous in the left thigh, instead of PREVNAR (wrong vaccine administered). No concomitant medications were provided. No adverse effects were reported. Additional information is not expected as the physician did not want to be contacted regarding the report because the patient was not longer with her practice.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and concerns an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (having lot # reported as L020188 and expiration date as 03-JUN-2017) (dose number, dosage and route of administration were not reported). No concomitant therapies were reported. No previous excursions had occurred. This temperature excursion occurred at 50 F for a time frame of one hour. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to multiple unspecified patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant medications were not reported. On 05-FEB-2016, the patients were administered improperly stored doses, by a time frame of an hours and 30 minutes with a temperature of 57F, of GARDASIL 9 (Lot # L048237, expiration date 08-MAY-2017; Lot # L016429, expiration date 09-AUG-2017; Lot # L018351, expiration date 11-AUG-2017). No adverse effect reported. There was no product quality complaint involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an expired dose of ZOSTAVAX, (lot # and expiry date not reported). Other co-suspect or concomitant medications were not reported. No adverse symptoms were reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-SEP-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-SEP-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-OCT-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. 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 physician referring to multiple unspecified patients of unknown age and gender. The patients medical histories, concurrent conditions and concomitant medications were not reported. On 05-FEB-2016, the patients were administered improperly stored doses, on a time frame of an hour and 30 minutes with a temperature of 57F, of oral ROTATEQ (Lot# L026741, expiration date 18-MAY-2017; Lot# L026740, expiration date 16-APR-2017). No adverse effect reported. There was no product quality complaint involved. This is one of the several reports from the same source. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-NOV-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 04-NOV-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.