chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Granuloma annulare, Pruritus generalised, Rash generalised
Clinical narrative: This spontaneous report as received from a consumer refers to a currently 76 years old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On 01-NOV-2010 the patient was vaccinated with the dose of ZOSTAVAX, one time injections (route of administration reported as injection, lot number was not reported), for the prevention of shingles. Concomitant therapies included DIOVAN. On an unknown date the patient developed an itchy rash all over her body called granuloma annulare after receiving ZOSTAVAX. Lab diagnostics studies were performed and included skin biopsy (results not provided). The patient sought medical attention via a doctor visit. The outcome of granuloma annulare was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. 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 unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with VAQTA, intramuscular. Route, dose, dose number, frequency and lot number were not reported. The nurse reported that improperly stored VAQTA may have been administered to unspecified patients. VAQTA was exposed to temperatures of 31.5F for 4 hours and 31.5F for 1.5 hours. No adverse effects were reported. This case is linked to 1309USA013283, 1309USA013284 and 1309USA013284 (same reporter link). Additional information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling
Clinical narrative: This spontaneous report as received via Publicist Field Representative from a non-pregnant female, pharmacist of unknown age refers to herself. In 2012 reported as (within the past year) when the reporting pharmacist administered the ZOSTAVAX injection for prevention of shingles she experienced a swelling of the eyes which later resolved on its own on an unknown date. The reporting pharmacist did not seek medical attention. The relatedness between ZOSTAVAX and a swelling of the eyes was not reported. 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 nurse refer to a patient (age, gender unknown). On an unknown date a patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date, dose, route not reported) for vaccination. No adverse event reported. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Injection site pain, Injection site pruritus, Injection site swelling, Local swelling
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 21 September 2013. A 56-year-old female patient had received an intradermal injection in the left deltoid of FLUZONE Intradermal (lot number not reported) on 13 September 2013. The night of the vaccination, the patient stated she didn't feel well and her bones ached. Her pain level was a 7-8 and she took prescribed meds hydrocodone and XANAX. The next day, the patient felt fine. A few hours into her day, the left deltoid became painful, swollen and itchy. On the right arm she developed two bumps the size of golf balls and broke out in pink round bumps scattered on her upper body. They were painful, swollen and itchy pink round bumps. She was seen at an urgent care center and prescribed Clindamycin. The rash was beginning to improve. The patient had a history of pain and reflex dystrophy. Outcome was not recovered. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pain, Rash erythematous, Rash pruritic
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 21 September 2013. A 56-year-old female patient had received an intradermal injection in the left deltoid of FLUZONE Intradermal (lot number not reported) on 13 September 2013. The night of the vaccination, the patient stated she didn't feel well and her bones ached. Her pain level was a 7-8 and she took prescribed meds hydrocodone and XANAX. The next day, the patient felt fine. A few hours into her day, the left deltoid became painful, swollen and itchy. On the right arm she developed two bumps the size of golf balls and broke out in pink round bumps scattered on her upper body. They were painful, swollen and itchy pink round bumps. She was seen at an urgent care center and prescribed Clindamycin. The rash was beginning to improve. The patient had a history of pain and reflex dystrophy. Outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant concerning a female patient of unknown age. On 13-SEP-2013, the patient was vaccinated with first dose of PNEUMOVAX23 (lot number and expiry date were reported as H022280 and 16-JUL-2014 respectively, dose and route unspecified). No concomitant therapy was reported. Approximately on an unknown date in September 2013, the patient developed injection site reaction as cellulitis with redness and swelling. The patient sought medical attention (seen in office). She was treated with BENADRYL. The outcome of the events was unknown. The relatedness for the events was unknown for PNEUMOVAX23. This is one of the two reports from the same source. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 44 year old female patient. Her relevant medical history and past drug history were unknown. On 30-AUG-2013, in the morning, the patient received a dose of GARDASIL, 0.5 ml, once (lot number, expiration date, indication, route and site of administration were not reported). Concomitant medications were unknown. On 30-AUG-2013, in the afternoon, the patient drank a glass of wine after having received the GARDASIL in the morning and was not feeling well. It was unknown if any laboratory testing were performed. As of 30-AUG-2013, she only received GARDASIL once and it was unknown if she continued to not feel well.  The nurse did not feel the event was related to receiving GARDASIL and drinking wine. 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 registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL, intramuscular. Route, dose, dose number, frequency and lot number were not reported. The nurse reported that improperly stored GARDASIL may have been administered to unspecified patients. GARDASIL was exposed to temperatures of 31.5 F for 4 hours and 31.5 for 1.5 hours. No adverse effects were reported. This case is lined to 1308USA014798, 1309USA013283 and 1309USA13285 (same reporter link). Additional information is expected.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Hepatitis C
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with Human immunodeficiency virus (HIV). On approximately 23-AUG-2013 reported as two weeks ago the patient was vaccinated with VARIVAX (Merck) (dose, route, lot number and expiration date not provided). The pharmacist further reported that patient had a prescription for PEGINTRON at the pharmacy and would like to start the PEGINTRON at 06-AUG-2013. Pharmacist could not clarify as to when the patient was diagnosed with hepatitis C. The outcome of hepatitis C was unknown. The relatedness between vaccination with VARIVAX (Merck) and M-M-R II and hepatitis C was not reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MEN, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 29 year old female patient with depression, exercise induced asthma, CELEXA and ULTRAM allergy who smoked 1.5 pack per day and a history of tubal occlusion and tubal reversal. On 26-AUG-2013 the patient was vaccinated with a dose of VARIVAX (Merck) injection (route, dose, lot number and exp. date not provided) and meningococcal vaccine (unspecified) (route, dose, lot number and exp. date not provided) for college entrance. The patient received vaccinations at unspecified facility. Concomitant therapies included WELLBUTRIIN, SEROQUEL and vitamins (unspecified). On 27-AUG-2013 the patient had received a positive pregnancy test. The patient sought medical attention-visited office. The ultrasound made on 05-SEP-2013 verified uterine pregnancy and gestational age was determined to be 4 weeks and 3 days on 26-AUG-2013, when patient received VARIVAX (Merck) and meningococcal vaccine (unspecified). Therapy with WELLBUTRIN and SEROQUEL was stopped on 27-AUG-2013. No treatment was given to the patient. No adverse reaction was reported. The outcome of events was unknown. The Last Menstrual Period (LMP) was reported as 26-JUL-2013 and Estimated Date of Delivery was 02-MAY-2014. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unknown age and gender patient. The reporter reported that the patient received three doses of VARIVAX (Merck) (lot # unspecified) route and location unspecified. The patient received the three doses of VARIVAX (Merck) as followed: first dose on 26-JUL-2011, second dose on 06-AUG-2012, and third dose 31-JUL-2013. No adverse effect reported. Additional information was received from the physician. This report concerns a 3 year old, male patient with no pre-existing allergies, birth defects or medical conditions. The patient had no adverse events following prior vaccination. Patient's weight was reported as 35-units not provided). On 31-JUL-2013 at 4:00 PM the patient was vaccinated subcutaneously in left arm with the third dose of VARIVAX (Merck) lot number reported as J001176 (expiration date not provided). On 03-AUG-2013 the patient experienced fever which started at 5:30 PM. There were not relevant diagnostic tests and laboratory data performed. He did not require the doctor visit or emergency room. The outcome of fever was unknown. The patient was healthy at the time of vaccination, there were the relatedness between the patient's adverse events and the vaccination with VARIVAX (Merck) was not provided. Additional information is not expected.
Sex: M
Vaccine: HEP, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a nurse's son, a child patient of unknown age. On approximately 15-AUG-2013 (reported as 3 weeks ago) the patient was vaccinated with the second dose of VARIVAX (Merck), injection (dose, route, lot number and expiration date not provided). Concomitant therapies included meningococcal vaccine (manufacturer unknown), first dose of GARDASIL, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) and first dose of hepatitis B vaccine (manufacturer unknown). On approximately 16-AUG-2013 (reported as formed one day post vaccination) the patient experienced severe local injection reaction, a large, hard lump that was red and hot to touch. All symptoms resolved within one week's time. A treatment was given for adverse event: CLARITIN or BENADRYL and supportive care (unspecified). Relatedness between vaccination with VARIVAX (Merck) and severe local injection reaction, a large, hard lump that was red and hot to touch was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist, as part of a marketing research program refers to an over 60 year old male patient (patient's exact age and ethnicity were unknown). On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date were not provided). The pharmacist reported that 1-2 years after receiving ZOSTAVAX injection the patient experienced shingles. On an unspecified date the patient recovered from shingles. Relatedness between the event of shingles and the vaccination with ZOSTAVAX was not reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. A few years ago, the patient was vaccinated with the first dose of GARDASIL (lot #, dose, route and indication was not reported). This licensed practical nurse reported that the patient did not receive their third dose of GARDASIL. At the time of reporting, the patient was in the office to receive the third dose but the time between the second dose and third dose, that patient would receive today (20-SEP-2013), it was outside the dose schedule recommendations of the product insert. No adverse effects reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea, Vomiting
Clinical narrative: Redness, swelling, warm to touch around injection site. Nausea/vomiting.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Disability, Laboratory test normal, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 74 year old female patient with diabetes and drug hypersensitivity to unspecified steroid. On 03-NOV-2012 the patient was vaccinated with ZOSTAVAX lot # H013943 expiration date 25-OCT-2013, 0.65 ml, subcutaneous. Concomitant medication was unspecified. On an unknown date after the vaccination, the patient experienced recurring sharp pains in her calf "along her shin line". The patient was seen by her unspecified primary care on an unspecified date, who performed multiple tests including an MRI. Neuropathy was ruled out. The reporter stated that the patient did not develop a rash of any kind. The pharmacist stated: "the pain has caused significant disability to the patient". The outcome of recurring sharp pains in her calf "along her shin line" was reported as not recovered. 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 pharmacist refers to an unspecified patient of unknown age and gender. On 16-SEP-2013 the patient was vaccinated with ZOSTAVAX (route, dose, frequency, lot# and expiration date unspecified). On 16-SEP-2013, the patient was administered ZOSTAVAX that may have gone through an unsupported temperature excursion from 10-SEP-2013 to 16-SEP-2013. No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient with Diabetes and none drug reactions. On 17-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # J000444, 0.65 ml, subcutaneously) in the left arm. On 20-SEP-2013 the patient experienced redness, soreness, a lump the size and shape of an egg at her left arm injection site. The outcome of the adverse events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age or gender. On an unknown date the patient was vaccinated with GARDASIL (lot#, expiration date, dose, route, indication not reported) outside of recommended schedule. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with shingles rash 9-24-13. Treated with FAMVIR, VALTREX and prednisone.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a female physician of age to receive the vaccine via company representative refers to herself. On an unknown date the patient experienced very severe rash. The outcome of very severe rash was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an infant female patient of unknown age. On an unknown date between 13-MAY-2013 and 14-JUN-2013 the patient was vaccinated with RECOMBIVAX HB (2.5/0.5 units not provided), (0.5 ml intramuscularly, dose number unknown) (lot # H020604 exp. date 10-FEB-2015). RECOMBIVAX HB that had a temperature excursion. No adverse effects were reported. This case is related with the following cases on same reporter link: 1307USA007921; 1309USA012210; 1309USA012211; 1309USA012212; 1309USA012213; 1309USA012214; 1309USA012215; 1309USA012216; 1309USA012217; 1309USA012218; 1309USA012219; 1309USA012220; 1309USA012222; 1309USA012223; 1309USA012224; 1309USA012225; 1309USA012226; 1309USA012227; 1309USA012228; 1309USA012229; 1309USA012230; 1309USA012231; 1309USA012232
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: 15 minutes after immun. tingling lips and (L) cheek - BENADRYL 25 mg given - pt. states takes 75 mg BENADRYL HS QD. Symptoms not abating - takes 25 mg BENADRYL - 20 minutes later feeling hot, throat swelling, EMS called to hospital at 11 AM.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eyelid oedema, Flushing, Pruritus, Rash
Clinical narrative: Patient was given FLULAVAL vaccine 9/26/13 at 1500. At 0200 9/27/13 she awoke with (L) eye swollen shut red-flushed face, rash on neck, itching on face/neck. Denied trouble breathing.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an infant male patient of unknown age. On an unknown date between 13-MAY-2013 and 14-JUN-2013 the patient was vaccinated with RECOMBIVAX HB (2.5/0.5 units not provided), (0.5 ml intramuscularly, dose number unknowm) (lot # H018691 exp. date 07-FEB-2015). RECOMBIVAX HB that had a temperature excursion. No adverse effects were reported. This case is related with the following cases on same reporter link: 1307USA007921; 1309USA012210; 1309USA012211; 1309USA012212; 1309USA012213; 1309USA012214; 1309USA012215; 1309USA012216; 1309USA012217; 1309USA012218; 1309USA012219; 1309USA012220; 1309USA012221; 1309USA012222; 1309USA012223; 1309USA012224; 1309USA012225; 1309USA012226; 1309USA012227;  1309USA012229; 1309USA012230; 1309USA012231; 1309USA012232. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain, Rash erythematous
Clinical narrative: Swollen arm, red rash, lots of pain.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an infant male patient of unknown age. On an unknown date between 13-MAY-2013 and 14-JUN-2013 the patient was vaccinated with RECOMBIVAX HB (2.5/0.5 units not provided), (0.5 ml intramuscularly, dose number unknowm) (lot # H018691 exp. date 07-FEB-2015). RECOMBIVAX HB that had a temperature excursion. No adverse effects were reported. This case is related with the following cases on same reporter link: 1307USA007921; 1309USA012210; 1309USA012211; 1309USA012212; 1309USA012213; 1309USA012214; 1309USA012215; 1309USA012216; 1309USA012217; 1309USA012218; 1309USA012219; 1309USA012220; 1309USA012221; 1309USA012222; 1309USA012223; 1309USA012224; 1309USA012225; 1309USA012226; 1309USA012227; 1309USA012228; 1309USA012229; 1309USA012230; 1309USA012232. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an infant female patient of unknown age. On an unknown date between 13-MAY-2013 and 14-JUN-2013 the patient was vaccinated with RECOMBIVAX HB (2.5/0.5 units not provided), (0.5 ml intramuscularly, dose number unknowm) (lot # H020604 exp. date 10-FEB-2015). RECOMBIVAX HB that had a temperature excursion. No adverse effects were reported. This case is related with the following cases on same reporter link: 1307USA007921; 1309USA012210;  1309USA012212; 1309USA012213; 1309USA012214; 1309USA012215; 1309USA012216; 1309USA012217; 1309USA012218; 1309USA012219; 1309USA012220; 1309USA012221; 1309USA012222; 1309USA012223; 1309USA012224; 1309USA012225; 1309USA012226; 1309USA012227; 1309USA012228; 1309USA012229; 1309USA012230; 1309USA012231; 1309USA012232. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Laboratory test normal, Local swelling, Pain in extremity
Clinical narrative: Arm was swollen, red, painful from elbow to shoulder. Patient came to ER, was kept over the night and given antibiotic.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Arthralgia, Guillain-Barre syndrome, Lethargy, Pain in extremity, VIIth nerve paralysis
Clinical narrative: 8/16/13 - FLUMIST administered. 8/25/13 - (R) leg pain. 8/27/13 - Seen in office leg and knee pain. 9/2/13 - Lethargy and facial droop. 9/3/13 - Dx w/ Guillain-Barre.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Guillain-Barre syndrome, Mobility decreased, Posture abnormal, Pyrexia, VIIth nerve paralysis
Clinical narrative: 8/16/13 - FLUMIST administered. 8/25/13 - (R) leg pain. 8/27/13 - Seen in office leg and knee pain. 9/2/13 - Lethargy and facial droop. 9/3/13 - Dx w/ Guillain-Barre.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Viral infection, Vomiting
Clinical narrative: 8/16/13 - FLUMIST administered. 8/25/13 - (R) leg pain. 8/27/13 - Seen in office leg and knee pain. 9/2/13 - Lethargy and facial droop. 9/3/13 - Dx w/ Guillain-Barre.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient immunized with FLUVIRIN and PNEUMOVAX on 9/18. FLUVIRIN administered IM using standard deltoid technique. PNEUMOVAX admins SC. No apparent reaction at time of admin. On 9/21, pt called reporting local injection site redness and swelling (severe). Worsened over 2 days. Treated in ER.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Patient immunized with FLUVIRIN and PNEUMOVAX on 9/18. FLUVIRIN administered IM using standard deltoid technique. PNEUMOVAX admins SC. No apparent reaction at time of admin. On 9/21, pt called reporting local injection site redness and swelling (severe). Worsened over 2 days. Treated in ER.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Feeling hot, Swelling face, Urticaria
Clinical narrative: Weakness, feeling hot, facial swelling generalized urticaria - went to a treatment center - was given prednisone (dose pack), PEPCID, and BENADRYL.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: This spontaneous report has been received from a nurse practitioner concerning to 68 year old female patient with morphine reaction, hydrocodone reaction and none pertinent medical history. On 17-SEP-2013, the patient was vaccinated with PNEUMOVAX23 injection, 0.5 ml, intramuscular in the left deltoid region of the arm, lot # H018608 and expiration date: 02-JUL-2014. Concomitant therapies included: MOBIC, ZESTRIL, TOPROL XL, PREMARIN, folic acid (manufacturer unknown), cholecalciferol vitamin D3 (manufacturer unknown) and IMODIUM. On 17-SEP-2013, within an unspecified number of hours after injection, the patient experienced redness, swelling "the size of a golf ball" and pain at injection site. On 17-SEP-2013, an unspecified amount of time later in the day, the patient experienced that the redness had progressed to her whole body "from her neck down to her ankles", but the redness on her body was not itchy. On 18-SEP-2013, the patient called the nurse practitioner to report the incident and to be evaluated, it was also reported that the patient experienced a great deal of pain and was not able to raise her arm above her head. None Laboratory diagnostics studies performed. At an unknown date, it was not give a treatment for AE; however the patient scheduled an appointment on 19-SEP-2013, to reevaluate and determine the treatment to manage the symptoms. On 19-SEP-2013, the patient was still experiencing the whole body redness and inability to raise her arm due to the pain. The outcome of the rest of the events was reported as not recovered. It was reported that the patient did not received treatment for the adverse events and no laboratory tests were performed. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: RAB
Symptoms: Blood test, Chills, Computerised tomogram, Culture, Hepatobiliary scan
Clinical narrative: Nausea/vomiting/chills 9/25/13, refractory vomiting. Fever 102 degrees 9/25/13. Pt presented to urgent care and was admitted to ICU by Dr.
Age: 61.0
Sex: M
Vaccine: RAB
Symptoms: Intensive care, Nausea, Pyrexia, Ultrasound abdomen, Vomiting
Clinical narrative: Nausea/vomiting/chills 9/25/13, refractory vomiting. Fever 102 degrees 9/25/13. Pt presented to urgent care and was admitted to ICU by Dr.
Age: 1.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an infant female patient of unknown age. On an unknown date between 13-MAY-2013 and 14-JUN-2013 the patient was vaccinated with RECOMBIVAX HB (2.5/0.5 units not provided), (0.5 ml intramuscularly, dose number unknowm) (lot # H020604 exp. date 10-FEB-2015). RECOMBIVAX HB that had a temperature excursion. No adverse effects were reported. This case is related with the following cases on same reporter link: 1307USA007921; 1309USA012210; 1309USA012211; 1309USA012212; 1309USA012213; 1309USA012215; 1309USA012216; 1309USA012217; 1309USA012218; 1309USA012219; 1309USA012220; 1309USA012221; 1309USA012222; 1309USA012223; 1309USA012224; 1309USA012225; 1309USA012226; 1309USA012227; 1309USA012228; 1309USA012229; 1309USA012230; 1309USA012231; 1309USA012232. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin reaction
Clinical narrative: Local skin rxn distal to injection site.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an infant male patient of unknown age. On an unknown date between 13-MAY-2013 and 14-JUN-2013 the patient was vaccinated with RECOMBIVAX HB (2.5/0.5 units not provided), (0.5 ml intramuscularly, dose number unknowm) (lot # H020604 exp. date 10-FEB-2015). RECOMBIVAX HB that had a temperature excursion. No adverse effects were reported. This case is related with the following cases on same reporter link: 1307USA007921; 1309USA012210; 1309USA012211;  1309USA012213; 1309USA012214; 1309USA012215; 1309USA012216; 1309USA012217; 1309USA012218; 1309USA012219; 1309USA012220; 1309USA012221; 1309USA012222; 1309USA012223; 1309USA012224; 1309USA012225; 1309USA012226; 1309USA012227; 1309USA012228; 1309USA012229; 1309USA012230; 1309USA012231; 1309USA012232. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an infant female patient of unknown age. On an unknown date between 13-MAY-2013 and 14-JUN-2013 the patient was vaccinated with RECOMBIVAX HB (2.5/0.5 units not provided), (0.5 ml intramuscularly, dose number unknown) (lot # H020604 exp. date 10-FEB-2015). RECOMBIVAX HB that had a temperature excursion. No adverse effects were reported. This case is related with the following cases on same reporter link: 1307USA007921, 1309USA012211, 1309USA012212, 1309USA012213, 1309USA012214, 1309USA012215, 1309USA012216, 1309USA012217, 1309USA012218, 1309USA012219, 1309USA012220, 1309USA012221, 1309USA012222, 1309USA012223, 1309USA012224, 1309USA012225, 1309USA012226, 1309USA012227, 1309USA012228, 1309USA012229, 1309USA012230, 1309USA012231, 1309USA012232. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an infant female patient of unknown age. On an unknown date between 13-MAY-2013 and 14-JUN-2013 the patient was vaccinated with RECOMBIVAX HB (2.5/0.5 units not provided), (0.5 ml intramuscularly, dose number unknowm) (lot # H018691 exp. date 07-FEB-2015). RECOMBIVAX HB that had a temperature excursion. No adverse effects were reported. This case is related with the following cases on same reporter link: 1307USA007921; 1309USA012210; 1309USA012211; 1309USA012212; 1309USA012213; 1309USA012214; 1309USA012215; 1309USA012216; 1309USA012217; 1309USA012218; 1309USA012219; 1309USA012220; 1309USA012221; 1309USA012222; 1309USA012223; 1309USA012224; 1309USA012225; 1309USA012226; 1309USA012227; 1309USA012228; 1309USA012229; 1309USA012231; 1309USA012232
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Localized swelling, redness, warmth, and itching at the injection site. Swelling 4cm round. BENADRYL 50 mg given IM and monitored for 30 minutes.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site haemorrhage
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported). Concomitant therapy was not reported. On an unknown date after patient received the vaccine there was blood in the injection site. The outcome of injection site bleeding was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site induration, Injection site nodule, Local swelling, Pruritus
Clinical narrative: Woke up with a headache, arm feverish and itching. Used a cold wash cloth and went back to sleep for awhile. Woke at 6:00 am - headache, arm swollen, red and feverish from below elbow to above my shoulder. At the site of the injection was a round hard knot the size of a baseball. Called Dr. He said to take Advil and I took BENADRYL that I had on hand - the swelling itch and redness finally slacked off 9-15-13. I still had a large brown area on my arm.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin discolouration
Clinical narrative: Woke up with a headache, arm feverish and itching. Used a cold wash cloth and went back to sleep for awhile. Woke at 6:00 am - headache, arm swollen, red and feverish from below elbow to above my shoulder. At the site of the injection was a round hard knot the size of a baseball. Called Dr. He said to take Advil and I took BENADRYL that I had on hand - the swelling itch and redness finally slacked off 9-15-13. I still had a large brown area on my arm.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a Certificate Medical Assistant (CMA) and registered nurse (RN) regarding a patient of an unknown age and gender. The RN stated that on 19-JUL-2013, the patient received a dose of PROQUAD (lot number J001052, expiration date 28-JUL-2014) (dose and route were not provided) that had been improperly stored. The R.N. stated that the patient had not experienced adverse effects. No additional details had been provided at that time. This is one of several reports from the same source (other MARRS #s 1308USA013854, 1309USA013044 and 1309USA013045). Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a Certificate Medical Assistant (CMA) and registered nurse (RN) regarding a patient of an unknown age and gender. The RN stated that on 02-AUG-2013, the patient received a dose of PROQUAD (lot number: J001052, expiration date 28-JUL-2014) (dose and route were not provided) that had been improperly stored. The RN stated that the patient had not experienced adverse effects. No additional details had been provided at that time. This is one of several reports from the same source (other MARRS #s 1308USA013854, 1309USA013043 and 1309USA013045). Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Delusion, Disorientation, Pyrexia, Tremor
Clinical narrative: Fever, shaking, disorientation, delusions were experienced the evening after receiving her vaccinations. Husband took pt to ED. Per husband pt was given BENADRYL in the ED.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a Certificate Medical Assistant (CMA) and registered nurse (RN) regarding a patient of an unknown age and gender. The RN stated that on 12-AUG-2013, the patient received a dose of PROQUAD (lot number: J001052, expiration date 28-JUL-2014)(dose and route were not reported) that had been improperly stored. The R.N. stated that the patient had not experienced adverse effects. No additional details had been provided at that time. This is one of several reports form the same soruce (other MARRS #s 1308USA013854, 1309USA013043 and 1309USA013044). Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site induration, Pain, Pyrexia
Clinical narrative: Redness, induration at injection site, pain, fatigue and fever after receiving vaccination. KEFLEX rx'd for 10 day course of treatment.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Induration redness in (L) tricep at inj site.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender unknown. Pertinent medical history, drug reactions or allergies were not reported. The pharmacist reported that an expired Merck sterile diluent (Lot number: G000184, expire date: 31-MAR-2012) was reconstituted with ZOSTAVAX (Lot number: J001004, expire date; 24-APR-2014) and given to a patient on 23-SEP-2013. Concentration, duration, route of administration and indication were not reported. No adverse events were reported. Concomitant medications were not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Flushing
Clinical narrative: Pt c/o flushing and "difficulty catching her breath" 10 min after getting vaccinated. EMS/911 was offered but pt refused. She remained in pharmacy a total of 40 minutes after vaccination. The flushing/dyspnea resolved, pt refused BENADRYL or water and 2 other offers to call EMS. RPh checked BP twice: 145/98 P 84. Pt said that is her normal BP.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Pt received flu vaccine on 9-20-13 in left deltoid IM. Presents on 9-23-13 with 17 x 18 cm warm, slightly tender, non indurated area at injection site.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Eye swelling, Injection site reaction, Local reaction, Swollen tongue
Clinical narrative: Swollen tongue, swollen eyes, bruising, local site reactions.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Left arm around injection site red hard area. Redness bigger than 50 cent piece.
Age: 37.0
Sex: M
Vaccine: FLUN4
Symptoms: Flushing, Palpitations, Pharyngeal oedema, Urticaria
Clinical narrative: 37 y/o male received LAIV4 around 0930. Patient awoke around 0200, with generalized flushing, palpitations, hives, and throat swelling. He self treated with oral BENADRYL 100 mg and symptoms started resolving in 30 minutes, and were completely resolved within 90 minutes. Symptoms have not recurred again. Felt well on day of vaccine receipt. No other possible exposures. No hx of previous vaccine adverse reactions.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash macular
Clinical narrative: States "about few hours after flu vax noticed she had itching red blotchy areas around neck and shoulder. This lasted several hours went away on own. No resp distress.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Feeling abnormal, Feeling cold, Feeling hot, Pain
Clinical narrative: By evening, became so cold and started shaking so hard for several hrs. Went to bed w/ heavy blanket and socks. Later became very hot. Ached all over. Was in bed 2 days miserable with red rash on torso, legs and arms that lasted itching for 3 days. Took BENADRYL.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Rash erythematous, Tremor
Clinical narrative: By evening, became so cold and started shaking so hard for several hrs. Went to bed w/ heavy blanket and socks. Later became very hot. Ached all over. Was in bed 2 days miserable with red rash on torso, legs and arms that lasted itching for 3 days. Took BENADRYL.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Information was received from a claims examiner referring to a male patient, age unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX lot # J003357, expiration date 21Jun14. On 09-SEP-2013, the patient experienced an adverse reaction (no further specified) to the ZOSTAVAX vaccine. The outcome of the adverse reaction is unknown. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Increased viscosity of bronchial secretion, Oropharyngeal pain, Sinus congestion
Clinical narrative: 3-4 hours after vaccine sore throat and sinus congestion through night, lungs felt hard to breathe. 4 days after bad cough with thick mucus.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Anticonvulsant drug level therapeutic, Convulsion
Clinical narrative: Hx ADHD, had seizure, lasting 3-4 min. Hx of myoclonic epilepsy. Usually takes KEPPRA 1000mg BID, RITALIN 20mg, clonazepam PRN. Seen at ER, observed. Sent home.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Since getting ZOSTAVAX, patient started getting a headache daily starting the day after getting the vaccination. She uses OTC medication to treat the headaches. Still having them 5 days after.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Local swelling
Clinical narrative: Swollen and red arm (Cam ein on 9/23/13).
Age: 1.05
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Activities of daily living impaired, Feeling hot, Oral disorder, Papule, Rash
Clinical narrative: One week after receiving shots, patient "got warm", got a rash, 2 lesions in mouth and some behind knees. Papules are clear liquid filled. Diagnosed with chickenpox. Treatment: Push fluids, treat fever, keep him out of daycare until lesions are crusted over.
Age: 1.05
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: One week after receiving shots, patient "got warm", got a rash, 2 lesions in mouth and some behind knees. Papules are clear liquid filled. Diagnosed with chickenpox. Treatment: Push fluids, treat fever, keep him out of daycare until lesions are crusted over.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling and warmth at site of injection after receiving vaccine.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Rash, Rash pruritic
Clinical narrative: One day after shot, rash started in the arm flu vaccine was given (L). Now rash on chest and itchy. There is a raised area at the site of the flu shot.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Irritability
Clinical narrative: After having DTAP on 7/16/13 pt cried at least 3 hours of non-stop crying. Pt was fussy for 2-3 wks, per parent, after vaccines.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Chills, Decreased appetite, Fatigue, Hyperhidrosis
Clinical narrative: Fatigue, muscle aches, chills, sweats, no appetite - onset same day. Red rash on arm. Symptoms peaked at day 4, followed up day 7, feeling a little better.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Rash, Rash erythematous
Clinical narrative: Fatigue, muscle aches, chills, sweats, no appetite - onset same day. Red rash on arm. Symptoms peaked at day 4, followed up day 7, feeling a little better.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling abnormal, Hypertension, Paraesthesia oral
Clinical narrative: Patient felt funny after vaccine. Felt like her lips and tongue were tingling and became hypertensive and dyspneic. Taken by ambulance to hospital.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Crying, Rash
Clinical narrative: Unconsolable crying for 2 hr 45 min, 4 hrs after receiving vaccines. Rash onset next morning prompting office visit. Dr recommended BENADRYL for pt and return to clinic if worsening.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Agitation, Injection site inflammation, Injection site swelling, Pyrexia
Clinical narrative: Injection site became swollen and inflamed, baby was agitated and had a fever of 100 degress F for 36 hours.
Age: 12.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Headache, Pyrexia
Clinical narrative: Difficulty breathing, fever, headache.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Arthralgia, Aspiration joint, Blood uric acid normal, Borrelia test
Clinical narrative: I had 4 joints (left middle toe, right ankle, left knee, and right index finger) that started to swell, decreased mobility, pain.  Got worse over the next 15 days and ended up on crutches.  I was started on prednisone in the beginning of November (still on crutches) and took this until June 2013.  The decreased mobility and pain were gone around April 2013, although slight swelling still exists in the right ankle today.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein, Haematocrit normal, Haemoglobin normal, Joint swelling, Mean cell haemoglobin concentration normal
Clinical narrative: I had 4 joints (left middle toe, right ankle, left knee, and right index finger) that started to swell, decreased mobility, pain.  Got worse over the next 15 days and ended up on crutches.  I was started on prednisone in the beginning of November (still on crutches) and took this until June 2013.  The decreased mobility and pain were gone around April 2013, although slight swelling still exists in the right ankle today.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Mobility decreased, Parvovirus B19 test negative
Clinical narrative: I had 4 joints (left middle toe, right ankle, left knee, and right index finger) that started to swell, decreased mobility, pain.  Got worse over the next 15 days and ended up on crutches.  I was started on prednisone in the beginning of November (still on crutches) and took this until June 2013.  The decreased mobility and pain were gone around April 2013, although slight swelling still exists in the right ankle today.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Platelet count normal, Red blood cell count normal, Red blood cell sedimentation rate normal, Red cell distribution width normal, Walking aid user
Clinical narrative: I had 4 joints (left middle toe, right ankle, left knee, and right index finger) that started to swell, decreased mobility, pain.  Got worse over the next 15 days and ended up on crutches.  I was started on prednisone in the beginning of November (still on crutches) and took this until June 2013.  The decreased mobility and pain were gone around April 2013, although slight swelling still exists in the right ankle today.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: White blood cell count normal
Clinical narrative: I had 4 joints (left middle toe, right ankle, left knee, and right index finger) that started to swell, decreased mobility, pain.  Got worse over the next 15 days and ended up on crutches.  I was started on prednisone in the beginning of November (still on crutches) and took this until June 2013.  The decreased mobility and pain were gone around April 2013, although slight swelling still exists in the right ankle today.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Ear swelling, Erythema, Eye pruritus, Eye swelling, Lip swelling
Clinical narrative: Woke up itching and breaking out in hives on my legs, back, and stomach.  My ears and eyes were slightly red and itching/swelling a little. My upper lip was also swollen.  It was a mild reaction.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pruritus, Urticaria
Clinical narrative: Woke up itching and breaking out in hives on my legs, back, and stomach.  My ears and eyes were slightly red and itching/swelling a little. My upper lip was also swollen.  It was a mild reaction.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal sensation in eye, Eye discharge, Eye irritation, Foreign body sensation in eyes, Visual impairment
Clinical narrative: Eyes began to burn.  They felt like something was stuck under the lid and scratching them.  It got worse and I was having a hard time seeing.  They felt really dry but at the same time were goopy and sticking together.  Around 9:30pm I came down with a fever and took 400mg of Advil and went to bed.  Woke up at 1am and felt worse so I took 400mg of Advil and put cold towels on my head.  At 11am my fever finally broke and my eyes started to clear up.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye irritation
Clinical narrative: Oozing and irritated eyes bilaterally.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Irritability, Pyrexia, Rash
Clinical narrative: Fever 102.6, rash, fussiness, diarrhea.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Agitation, Dyspnoea, Pyrexia, Urticaria
Clinical narrative: Hives, fever, agitation, SOB.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Neck pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: VACCINE GIVEN IN LEFT DELTOID.  ARM SWELLED, PAINFUL, WARM TO TOUCH.  PAIN RADIATING UP NECK. FEVER 99.7.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Very sore deltoid area of arm.  The vaccine was administered a bit too high in my arm.  When I move my arm and my deltoid is used in the movement, a sharp pain travels through my deltoid. I saw my physician on 09/24/2013 because the pain was not getting any better.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Computerised tomogram, Lymphadenitis, Lymphadenopathy, Neck pain, Pain in jaw
Clinical narrative: Fever (102.5 F), vomiting, jaw/neck pain started 9/14/13, swelling in parotid and lymph gland and ER visit 9/15/13, hospitalized 9/15-9/18 for IV antibiotics for acute lymphadenitis.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Parotid gland enlargement, Pyrexia, Ultrasound scan, Vomiting, X-ray
Clinical narrative: Fever (102.5 F), vomiting, jaw/neck pain started 9/14/13, swelling in parotid and lymph gland and ER visit 9/15/13, hospitalized 9/15-9/18 for IV antibiotics for acute lymphadenitis.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fear, Pharyngeal oedema
Clinical narrative: Client reported that she went to the nurse because her throat was swelling and she got scared that she couldn't breath.