chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion induced, Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy registry report for GARDASIL was received from a licensed practical nurse concerning a 15 years old female patient. The patient had no pertinent medical history or drug reactions/allergies. Gravida 1 (current pregnancy) and Para 0. The pregnant patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL on 28-AUG-2012. Lot # (1860AA). No other co-suspects were reported. No concomitant medications were reported. As of 11-OCT-2012 gestation period was 21 weeks with a LMP of 17-MAY-2012 and an EDD of 21-FEB-2013. Initial exposure to GARDASIL was at 15 weeks during trimester 2 of pregnancy. No adverse effects were reported. No treatment information was reported. Outcome was unknown. Follow up information was received from the licensed practical nurse. It was reported that the patient electively terminated her pregnancy, mom did fine with the procedure and there were no complications. The relatedness for the event was unknown for GARDASIL. Upon internal review, patient electively terminated her pregnancy was considered as medically significant. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion induced, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy registry report for GARDASIL was received from a licensed practical nurse concerning a 15 years old female patient. The patient had no pertinent medical history or drug reactions/allergies. Gravida 1 (current pregnancy) and Para 0. The pregnant patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL on 28-AUG-2012. Lot # (1860AA). No other co-suspects were reported. No concomitant medications were reported. As of 11-OCT-2012 gestation period was 21 weeks with a LMP of 17-MAY-2012 and an EDD of 21-FEB-2013. Initial exposure to GARDASIL was at 15 weeks during trimester 2 of pregnancy. No adverse effects were reported. No treatment information was reported. Outcome was unknown. Follow up information was received from the licensed practical nurse. It was reported that the patient electively terminated her pregnancy, mom did fine with the procedure and there were no complications. The relatedness for the event was unknown for GARDASIL. Upon internal review, patient electively terminated her pregnancy was considered as medically significant. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion induced, Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy registry report for GARDASIL was received from a licensed practical nurse concerning a 15 years old female patient. The patient had no pertinent medical history or drug reactions/allergies. Gravida 1 (current pregnancy) and Para 0. The pregnant patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL on 28-AUG-2012. Lot # (1860AA). No other co-suspects were reported. No concomitant medications were reported. As of 11-OCT-2012 gestation period was 21 weeks with a LMP of 17-MAY-2012 and EDD of 21-FEB-2013. Initial exposure to GARDASIL was at 15 weeks during trimester 2 of pregnancy. No adverse effects were reported. No treatment information was reported. Outcome was unknown. Follow up information was received from the licensed practical nurse. It was reported that the patient electively terminated her pregnancy, mom did fine with the procedure and there were no complications. The relatedness for the event was unknown for GARDASIL. Upon internal review, patient electively terminated her pregnancy was considered as medically significant. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion induced, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy registry report for GARDASIL was received from a licensed practical nurse concerning a 15 years old female patient. The patient had no pertinent medical history or drug reactions/allergies. Gravida 1 (current pregnancy) and Para 0. The pregnant patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL on 28-AUG-2012. Lot # (1860AA). No other co-suspects were reported. No concomitant medications were reported. As of 11-OCT-2012 gestation period was 21 weeks with a LMP of 17-MAY-2012 and EDD of 21-FEB-2013. Initial exposure to GARDASIL was at 15 weeks during trimester 2 of pregnancy. No adverse effects were reported. No treatment information was reported. Outcome was unknown. Follow up information was received from the licensed practical nurse. It was reported that the patient electively terminated her pregnancy, mom did fine with the procedure and there were no complications. The relatedness for the event was unknown for GARDASIL. Upon internal review, patient electively terminated her pregnancy was considered as medically significant. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to her father: a male patient of unknown age. The patient's medical history included shingles. On an unknown date the patient was vaccinated twice with ZOSTAVAX. Concomitant medication was not provided. Since patient received the vaccine, he had continuously gotten shingles. At the time of the report (start date not provided), patient had shingles on his eyes. The outcome of the adverse events was not reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a Community Nursing Service refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route not reported) lot # J003727, expiry date 07-NOV-2015. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 25-OCT-2013 the patient was vaccinated with an improperly stored dose of GARDASIL, which was exposed to 31F for 1 hour, (lot # J003727, Exp date: 07-NOV-2015), 0.5 ml, intramuscularly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: HIGH DOSE FLUZONE given to patient under 65 yr. Telephone call to client 10/8/13. Message left. No response. 10/16/13. Telephone call advised # disconnected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: This spontaneous report as received from a physician refers to a 63 year old female patient. On 23-OCT-2013 the patient was vaccinated with dose 2 of PNEUMOVAX23 (lot # J006242, 0.5 ml). The reporter reported patient was administered PNEUMOVAX23 which was less than 5 years after administration of first dose, dated 01-DEC-2013. Patient was experiencing severe localized reaction, which began sometime during the evening of injections on 23-OCT-2013, involving swelling, redness and pain surrounding the injection site. The patient sought medical attention from the physician and got no treatment. The outcome of the adverse events was reported as not recovered.  Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. On 25-JUN-2013 and 27-AUG-2013 the patient was vaccinated with the first dose and the second dose of ROTATEQ, suspension 2, (lot#, expiration date and route unspecified). On 28-OCT-2013 the patient was vaccinated with improperly stored of ROTATEQ, suspension 2, (lot # J007283, expiration date 27-SEP-2014 and dose unspecified). No adverse event reported. This is one of several reports received from same source. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 19 month old patient of unknown gender. The nurse reported that the patient received a dose of VARIVAX (Merck) (lot# unspecified) (route, dose and location unspecified) on 09-APR-1999 and then vaccinated with a dose of M-M-R II (lot# unspecified) (route, dose and location unspecified) on 19-APR-1999. The patient had received VARIVAX (Merck) and M-M-R II at different times within a period less than 28 days. No adverse effect reported. This is one of several reports received from the same reporter. Follow up information had been received from the Registered Nurse refers to the currently 16 year old male patient. It was reported that their school records showed this child was given live vaccine too close together. Their office did not give any of these. They were trying to connect the problem. Varicella dose was given on 09-APR-1999 and did get chickenpox later date. M-M-R II dose was given on 19-APR-1999 by another agency. They gave another M-M-R II on 09-OCT-2013. There was no problem with the child. The patient did not require emergency room/doctor visit. The outcome was not provided. 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 registered nurse. On an unknown date, at least two patients was vaccinated with the second dose of GARDASIL (lot#, dose, frequency, unspecified) about a year after the first dose of GARDASIL. No demographics or dates available at the time of the report. No adverse event reported. Additional information is not expected.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain, Pain
Clinical narrative: Pt states he developed neck pain and side pain on the side of the body in which the flu shot was given. Lft arm.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (dose and route unknown)(lot# H020255, exp date 08-NOV-2014). It was reported that the vaccine was improperly stored vaccine (start date unknown). The outcome and action taken not provided. Additional information has been requested.
Sex: U
Vaccine: DTAP, FLU3, PPV
Symptoms: Chills, Decreased appetite, Local swelling, Nasal congestion
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H015749, expiry date 08-JUN-2014). The patient was also vaccinated with a dose of DTaP (manufacturer unknown) and AFLURIA on the same day. On an unknown date, the patient experienced severe nasal congestion, chills, arm swelling and loss of appetite. The outcome of severe nasal congestion, chills, arm swelling and loss of appetite was reported as not recovered The patient sought medical attention. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. On 28-AUG-2013 the patient was vaccinated with the first dose of ROTATEQ, suspension 2, (lot#, expiration date and route unspecified). On 28-OCT-2013 the patient was vaccinated with improperly stored of ROTATEQ, suspension 2, (lot# J007283, expiration date 27-SEP-2014 and dose unspecified). No adverse event reported. This is one of several reports received from same source. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to a 70 years old female patient with no drug reactions/allergies. On 23-OCT-2013, the patient was vaccinated with a dose of PNEUMOVAX23, (lot number J004056 is an invalid not number for PNEUMOVAX23, Exp date 22-JUL-2014), (dose not reported), intramuscular on the left deltoid in the physician's office. Other suspect therapies was ZOSTAVAX, (lot#, dose, route and anatomical location not reported) received in patient's local unspecified pharmacy at the same day. Concomitant medications included unspecified cholesterol medication and unspecified high blood pressure medication. The reporter stated that patient was seen in the physician's office on 25-OCT-2013, with redness, swelling, tenderness and warmth that initially started at injection site but had now spread all the way down the left arm past the elbow. The patient received an injection of DEPO-MEDROL and a prescription of KEFLEX as treatment for the symptoms of the PNEUMOVAX23 injection site reaction. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Local swelling, Skin warm, Tenderness
Clinical narrative: This spontaneous report as received from a nurse refers to a 70 years old female patient with no drug reactions/allergies. On 23-OCT-2013, the patient was vaccinated with a dose of PNEUMOVAX23, (lot number J004056 is an invalid not number for PNEUMOVAX23, Exp date 22-JUL-2014), (dose not reported), intramuscular on the left deltoid in the physician's office. Other suspect therapies was ZOSTAVAX, (lot#, dose, route and anatomical location not reported) received in patient's local unspecified pharmacy at the same day. Concomitant medications included unspecified cholesterol medication and unspecified high blood pressure medication. The reporter stated that patient was seen in the physician's office on 25-OCT-2013, with redness, swelling, tenderness and warmth that initially started at injection site but had now spread all the way down the left arm past the elbow. The patient received an injection of DEPO-MEDROL and a prescription of KEFLEX as treatment for the symptoms of the PNEUMOVAX23 injection site reaction. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a female patient of unknown age regards herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number, dose, frequency, route and site of administration were not reported). On an unknown date the patient developed a rash the size of a softball around the injection-site, where she received ZOSTAVAX. The outcome of rash the size of a softball around the injection-site was not reported. The relatedness between therapy with ZOSTAVAX and rash the size of a softball around the injection-site was not reported. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a 65 year old female patient. On an unknown date, when the patient was 64 years old, she was vaccinated with ZOSTAVAX dose 1, 0.65 ml, subcutaneously. On an unknown date, when the patient was 65 years old, she inadvertently received a second dose of ZOSTAVAX, 0.65 ml, subcutaneously. No symptoms were reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 14 year old female patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot # not reported) on 19-NOV-2012. No other co-suspects were reported. There were not concomitant medications. The physician reported that on 19-NOV-2012 the patient was administered her first dose of GARDASIL and a subsequent urine pregnancy test was positive on that date. The patients LMP (approximately in 2012) and EDD were unknown. Initial exposure to GARDASIL was at an unknown gestational period. The patient sought medical attention at the office3. No treatment was given and the patient was referred to an obstetrician for follow up care. Complete blood count and metabolic panel were also ordered on 19-NOV-2013 (results not provided). Follow up information was received which stated that EDD was approximately July 2013. Additional information has been requested.
Sex: U
Vaccine: DTAP, PPV
Symptoms: Decreased appetite, Nasal congestion, Weight decreased
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H015749, expiry date 08-JUN-2014). The patient was also vaccinated with a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) on the same day. On an unknown date, the patient experienced severe nasal congestion and loss of appetite. The patient had lost 134 pounds since these vaccines were administered. The outcome of the reported events were not recovered. The patient sought medical attention. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patietn. On approximately 22-OCT-2013 (last week) the patient was vaccinated with a dose of ZOSTAVAX (lot # J006829, expiration date 14-SEP-2014, dose and route unspecified) for shingles. In 2013 the patient experienced swelling and soreness at the injection site on the back of the arm. The patient called the pharmacy regarding the reaction. The patient was treatment with ice pack and over the counter pain relievers. The event outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. On approximately 22-OCT-2013 (last week) the patient was vaccinated with a dose of ZOSTAVAX (lot # J006829, expiration date 14-SEP-2014, dose and route unspecified) for shingles. In 2013 the patient experienced swelling and soreness at the injection site on the back of the arm. The patient called the pharmacy regarding the reaction. The patient was treatment with ice pack and over the counter pain relievers. The event outcome was unknown. This is one of several reports received from same source. Additional information has been requested.
Age: 70.0
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old patient of unknown gender. The reporter stated that the patient was administered a dose of PNEUMOVAX 23 (dose, strength, lot #, route and site of administration not reported) within the past five years and subsequently was administered another dose of PNEUMOVAX 23 intramuscular (dose, strength, lot # and site of administration not reported) on 08-OCT-2013. No adverse effect reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a 19 year old female patient. Medical history and drug reactions/allergies were not reported. On 28-JUL-2008, the patient was vaccinated with GARDASIL first dose, 0.5 ml, intramuscular for vaccination (lot not reported). On 13-JUL-2010, the patient was vaccinated with GARDASIL second dose, 0.5 ml, intramuscular for vaccination (lot not reported). On 08-AUG-2013, the patient was vaccinated with GARDASIL third dose, 0.5 ml, intramuscular for vaccination (lot not reported). Concomitant medication was not reported. The patient did not seek for medical attention. No adverse effects reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Infection, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 58 year old female patient. Current conditions included allergy to cephalosporins, quinolones (reaction: swelling) and penicillins (reaction: rash) and fibromyalgia. On 14-OCT-2013 the patient was vaccinated with a dose of 0.65 milliliter (ml) ZOSTAVAX (lot # and expiration date was unknown), subcutaneously in the left arm. On 15-OCT-2013, patient developed redness and rash at injection site. On 18-OCT-2013, rash had spread from deltoid region to elbow and was warm to touch. Physician diagnosed patient with cellulitis and infection. Treatment was given for the events: doxycycline and prednisone were initiated. Medical attention was sought for the events. The events did not resolve at the time of this report. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: This spontaneous report as received from a female patient of unknown age regarding herself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was unknown). On an unknown date, the patient experienced redness and a hard bump at the injections site. The outcome of the events were unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old female patient. On 23-OCT-2013 the patient was vaccinated with the second dose of GARDASIL (0.5 ml, intramuscular in the left arm, lot number not reported). On 23-OCT-2013 after receiving GARDASIL, in the medical office, the patient became unresponsive while still in the office. The patient's eyes were open and she exhibited tonic clonic movements. She did not lose function of her bowels or bladder. This occurred over a 1 minute period and then the patient became alert. No lab test performed. The patient was observed for 20 minutes and then left the office. The outcome for both events was reported as recovered on 23-OCT-2013. The relatedness between GARDASIL and events was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a 61 year old female patient regarding herself. The pertinent medical history was none. It was unspecified if the patient had drug allergies or reactions. On an unknown date in 2007, the patient was vaccinated with a dose of PNEUMOVAX23, (lot number, expire date was unknown). Concomitant therapies included TETANUS AND DIPHTHERIA TOXOIDS ABSORBED and also administered on the same day. On an unknown date in 2007, the patient experienced warm itchy bumpy sensation after receiving PNEUMOVAX23. There was no treatment rendered for the events. There was no lab tests performed. The outcome of the reported events were reported as recovered on an unknown date in 2007. The patient sought medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 25-OCT-2013 the patient was vaccinated with an improperly stored dose of GARDASIL, which was exposed to 31F for 1 hour, (lot # J003727, Exp date: 07-NOV-2015), 0.5 ml, intramuscularly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 year old female patient. The patient's medical history included history of chicken pox, itching and unknown skin condition with red spots which is not eczema and it's not psoriasis, history of itching using an antihistamine for it. On 14-OCT-2013, the patient was vaccinated with ZOSTAVAX, (lot number, expiry date was unknown). Concomitant therapies included Atarax. On an unknown date in Oct-2013, the patient had little bumps around the injections site and the pharmacist believed it to be a shingles rash. Lab test were unknown. It was unknown if she would ever have ZOSTAVAX again. The outcome of the reported event was not recovered. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a healthcare worker via company representative refers to a patient of unknown age and gender with intussusception. On an unknown date the patient was vaccinated with ROTATEQ (route, dosage, dose number and lot number unknown). It was reported that the patient experienced severe vomiting after receiving ROTATEQ. The patient was hospitalized (length of stay and hospital unspecified). The patient sought medical attention (hospitalized) and received treatment (unspecified). The patient was reported as recovered from the event (unknown date). Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 64 year old female patient with dermerol allergy and penicillin allergy. On 28-OCT-2013 the patient was vaccinated with ZOSTAVAX dose 1, 0.65 ml (route and lot number unknown). Concomitant therapies included Synthroid, Primperam, Cymbalta and Lisinopril. On 29-OCT-2013, 1 day after onset of therapy the patient experienced an injection-site reaction. On Tuesday, 29-Oct-2013, she experienced a spot on her arm that was about an inch wide that was warm and hard. Then on Wednesday, 30-OCT-2013, it expanded by 2 inches and its warm and hard. The patient took some Advil on Tuesday for treatment. The outcome of spot on her arm that was warm and hard was reported as not recovered/not resolved. The reporter's relatedness of spot on her arm that was warm and hard to ZOSTAVAX is unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 28-OCT-2013 the patient was vaccinated with ZOSTAVAX (route and dose unknown) lot # J001729 dose 1. On 28-OCT-2013 the patient received expired ZOSTAVAX. No adverse symptoms reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pain in arm with decreased range of motion since vaccination on 10/11.
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient, greater than 26 years of age, with HIV. On an unknown date the patient was vaccinated with GARDASIL dose, route and lot # unknown. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2013US022535 is an initial spontaneous report received from a nurse on 24 Oct 2013: This report refers to a 44-year-old female patient. Her medical history included asthma. She was vaccinated with FLUVIRIN (batch number: 1308101 and expiry date: Mar 2014) on 30 Sep 2013. On the same day after vaccinations, she developed a red, raised and hot reaction at the injection site after vaccination as well as asthmatic symptoms. The reaction was the size of a baseball/softball. She was treated with asthmatic medication DULERA and was given SOLUMEDROL shot. SOLUMEDROL shot resolved the reaction and she was stable when she left the pharmacy. It was reported that the event resolved in less than one day. No further information about seriousness and causality was reported.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Within 2 hours of being vaccinated, the patient had a warm raised, red area, about 3-4 mm at site of injection. The next day, 10/30 the area remained red and induration was 9 mm. On 11/1 injection site was 11 mm and patient was advised to contact primary doctor for oral antibiotics.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Joint stiffness
Clinical narrative: Pain and stiffness in shoulder where injected. Unable to move arm. Dr sent patient to physical therapy.
Age: 1.07
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Condition aggravated, Urticaria
Clinical narrative: Child given MMR, VARIVAX, Flu and hepatitis A vaccines on 10/22. Soon after developed hives to both thighs which spread to face and trunk. No distress or anaphylaxis. Presented on 10/24 for evaluation - given BENADRYL for prn use. Has URI also.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Vertigo presented 3 weeks after vaccination and lasted 3 days - treated symptomatically.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pain in extremity
Clinical narrative: Left arm redness, edema, warmth, pain at injection site - Patient's PCP recommended ice and MOTRIN. 10/22 redness, edema and warmth gone but arm extremely sore.
Age: 71.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Entire (L) upper arm is red and swollen (left arm) and warm to touch. Evaluated by Dr. Treated with ibuprofen, local ice.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: Red and swollen upper arm to elbow.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient was unable to move arm in which vaccine was given (left). Called doctor, but did not go in. Was able to feel a little relief the next morning.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling, redness, itching. Treated with BENADRYL.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Inflammation, Musculoskeletal stiffness, Skin infection, Skin warm
Clinical narrative: Patient had warm, stiff feeling in arm and redness/inflammation 4-6" in diameter. Doctor is treating her for skin infection. Treatment for reaction is Doxycycline 100 mg BID and Antihistamine BID.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of VARIVAX dose, route and lot # not specified. On an unknown date after vaccination the patient experienced shingles. The patient was seen by the physician "a few days" after the rash developed. The physician reported that the shingles developed on the "opposite arm that was injected". The outcome of shingles was unknown. The relatedness between adverse event and VARIVAX was unknown. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Injection site pruritus, Paraesthesia
Clinical narrative: Itching at site - 5 min. Itching to left ear - 15 min. Tingling feeling to face - 20 min. Raspy voice - 20 - 30 min. Pt took ALAVERT and CLARITIN.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that a patient received an expired dose of PNEUMOVAX23 lot# 0491AE, expiration date: 15-SEP-2013 on 29-OCT-2013. No adverse effect reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Delayed pain and limited mobility to injection site (L) arm that started 3/4 d. after injection. Had done heavy activity with it so sought medical F/U including MRI and other tests. MD stated to client there is no damage and the pain is due to too deep of injection. Denies pain in flu shot site. Limited mobility and pain continues up by socket of shoulder mildly.
Age: 89.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Not able to lay on shoulder. Pain and limited mobility in left arm. Gradual improvement.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness and warmth at injection site 10 x 13cm. Pain at injection site (minimal). Cold compress advised (apple to reddened area).
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and warmth at injection site 10 x 13cm. Pain at injection site (minimal). Cold compress advised (apple to reddened area).
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye pruritus, Flushing, Lacrimation increased, Pain
Clinical narrative: Scratchy throat, watery and itchy eyes, SOB. Flushed and body aches.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Scratchy throat, watery and itchy eyes, SOB. Flushed and body aches.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an other refers to a patient of unknown age. On an unknown date, the patient was vaccinated (route not provided) with PROQUAD (lot number H021358, expiry date 23-NOV-2014). On an unknown date, an improperly stored vaccine used. The outcome of improperly stored vaccine used is unknown. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Cannot be properly communicated in this small space. Full anaph. reaction w/Dr's office 1st then ambulance, then ER.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Rash
Clinical narrative: Recd flu shot on 9/28/13. 9/30/13 noticed slight rash which spread over next few days and was diagnosed as shingles on 10/3.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Skin warm, Swelling
Clinical narrative: Deltoid area swollen 4x4 1/2 inches warm to touch, BENADRYL Q 6 hrs, TYLENOL PRN.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with MMR II (dose, concentration, lot number and expiration date were not provided). The reporter stated that on an unknown date, an unspecified facility had not calibrated their thermometer in the refrigerator that was storing MMR II vaccine for approximately 10 months. During a recent audit by the health department, it was revealed that the MMR II vaccine had been exposed to 47F to 50F for this period of time. It was not known whether or not any of the patients who received these improperly stored doses of MMR II vaccine had experienced any adverse effects. This is one of several reports received from same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Full blood count, Hepatic enzyme increased, Local swelling, Metabolic function test
Clinical narrative: Walks into clinic 11-1-13 at 8:00 am. C/O redness and Rt arm swelling painful area and fever. Rt arm has area of erythema 7 cm x 5.3 cm Rt arm. Elevated liver enzymes. Low platelets.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Platelet count decreased, Pyrexia
Clinical narrative: Walks into clinic 11-1-13 at 8:00 am. C/O redness and Rt arm swelling painful area and fever. Rt arm has area of erythema 7 cm x 5.3 cm Rt arm. Elevated liver enzymes. Low platelets.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Stated after flu shot - diffuse itching.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with ROTATEQ (dose, concentration, lot number and expiration date were not provided). The reporter stated that on an unknown date, an unspecified facility had not calibrated their thermometer in the refrigerator that was storing ROTATEQ vaccine for approximately 10 months. During a recent audit by the health department, it was revealed that the ROTATEQ vaccine had been exposed to 47F to 50F for this period of time. It was not known whether or not any of the patients who received these improperly stored doses of ROTATEQ vaccine had experienced any adverse effects. This is one of several reports received from same source. Additional information has been requested.
Age: 81.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Tenderness
Clinical narrative: Patient was given Pneumococcal on 10/24/13, by late day arm was very sore, could not sleep on that side. Site red, warm. By the next day was much better, day after that fine.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Musculoskeletal pain
Clinical narrative: (R) deltoid muscle area red and swollen (entire area surrouding injection area). Shoulder very sore. Patient has trouble lifting (R) arm.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Dizziness, Pallor, Paraesthesia, Presyncope
Clinical narrative: Nasal flu vaccine administration Sat AM, 5-10 min later pt pale, near syncopal. Vitals WNL. Pt's breakfast that AM and had played a sport. 2 days later again felt faint (tingly) at school. (-) exam at that time.
Age: 65.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Chills, Lethargy, Muscle fatigue, Pain in extremity, Pyrexia
Clinical narrative: Vaccinations given at 12:15 PM, at 9 M that day he started to experience chills with a fever, lethargic ness, sore arm and muscle fatigue. Wife called me about 3PM the following day reported that the symptoms have yet to resolve.
Age: 54.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Back pain, Breast pain, Chills, Local swelling
Clinical narrative: Arm swelled up and severe pain right down to wrist including back and right breast. Fever and chills.
Age: 54.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm swelled up and severe pain right down to wrist including back and right breast. Fever and chills.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Four hours after flu vaccine injected in L deltoid muscle, her L upper arm started swelling, became bright red and very painful affecting the full circumference of the upper arm. Forty eight hours later the swelling resolved and the upper arm was purple and itched. Patient has history of overactive immune system and vasculitis.
Age: 74.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Temperature, chilled, fever top 102 degrees, from knees down to ankles pain symptoms came back 2 weeks later.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: In the right arm deltoid region where AFLURIA was administered: patient reported a 6-7 inch red swollen area with a 3 inch bulls eye region. It was red, inflamed and warm to touch. Patient medicated with BENADRYL reported no other symptoms. After several follow-up calls patient reported on 10/30/13 reaction had almost completely recovered.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Injection site streaking, Pain
Clinical narrative: 6 - 7 inch rash around injection site and streaking. Itches. She states she was sore the first night then it started to feel better.
Age: 45.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient received PNEUMOVAX - 10/4/13. Arm was just slightly sore that night, The next day it was very sore, ROM very limited. Said if he had had to work, could not have. The next day much improved, day after fine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Blister, Rash, Rash erythematous, Skin lesion
Clinical narrative: Patient developed lesions resembling blisters/pimples on face and red spots on legs.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Erythema, Nausea, Tenderness, Vomiting
Clinical narrative: Nausea the evening of vaccination. Vomiting and diarrhea the following day. Also red arm with tenderness - 2 to 3" in diameter - almost all the way around the arm and lasted about 1 week.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction, Pain in extremity
Clinical narrative: Patient had a very bad reaction. Pain in arm started late afternoon of shot, pain went down into fingers. Took 2 days to resolve. No redness or swelling.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Injection site pain, Pain, Respiratory tract congestion
Clinical narrative: Woke up morning of 10/30/13 with congestion, body aches, headache, nasal drainage. Took ALEVE and Aspirin and a allergy medication with minimal results. Arm where injected was also sore to move. Today is 11/01/13 and I'm feeling very tired yet even with adequate rest.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Woke up morning of 10/30/13 with congestion, body aches, headache, nasal drainage. Took ALEVE and Aspirin and a allergy medication with minimal results. Arm where injected was also sore to move. Today is 11/01/13 and I'm feeling very tired yet even with adequate rest.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Asthenia, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Pt received HD flu et pneumonia 23 on 10/24/13. Reports that evening she had redness et swelling at site. Reports Friday she was so weak she couldn't get out of bed, SOB with chest discomfort, lightheadedness et rapid heart beat. Reports feeling hot/cold but didn't take temp. Symptoms lasted 2 days.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling of body temperature change, Heart rate increased, Injection site erythema, Injection site swelling
Clinical narrative: Pt received HD flu et pneumonia 23 on 10/24/13. Reports that evening she had redness et swelling at site. Reports Friday she was so weak she couldn't get out of bed, SOB with chest discomfort, lightheadedness et rapid heart beat. Reports feeling hot/cold but didn't take temp. Symptoms lasted 2 days.
Age: 1.37
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Pt. was given only Hib diluent - powder vial was not reconstituted and not given. No adverse reactions noted. Pt. was revaccinated per CDC recommendation.
Age: 0.45
Sex: F
Vaccine: RV5
Symptoms: Flatulence, Inappropriate schedule of drug administration, Nasopharyngitis
Clinical narrative: This spontaneous report was received from a physician refers to a 5 month old female patient. The patient's medical history included reflux and unspecified gastrointestinal symptoms. On 09-OCT-2013, the patient was administered a third dose of ROTATEQ (lot#, expiry not reported), 2 ml, orally earlier than recommended. The first dose of ROTATEQ (lot#, expiry not reported) was administered on 16-AUG-2013, and the second dose of ROTATEQ (lot#, expiry not reported) was administered on 18-SEP-2013. Concomitant therapies included PRILOSEC. The physician reported that the physician usually has unspecified gastrointestinal symptoms. However, the patient had extra gastrointestinal gas during the weekend of 11-OCT-2013 to 13-OCT-2013. Patient sought medical attention. The physician also reported that the patient was seen in her office on 17-OCT-2013, and the patient had developed a cold on an unspecified date in October 2013. No treatment was given. No laboratory tests were performed. The physician reported that the patient's gastrointestinal gas has completely improved on an unknown date in 13-OCT-2013. However, the physician was unaware if the patient had recovered from the cold. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Came into the Health Department on 10/28/13 and was given an influenza and a pneumonia vaccine. Patient stated that after receiving his immunizations, that night he had a fever of 100.4F that last less than 24 hours. Patient complained on tenderness at injection site also. Patients stated that on the morning of 10/30/13 he noticed his left upper arm was red and warm to the touch. The redness started at the injection site and spread to the inside of his left upper arm. Patient stated he followed up with his doctor, on 10/30/13. Patient stated his doctor asked if he was allergic to eggs - patient denied an egg allergy. Patient stated administered a cortisone injection in 10/30/13. Patient stated that since injection was given, redness is lighting in color and left upper arm is no longer warm to the touch. Patient stated Dr. was not sure what had caused the reaction, since the patient has had the influenza vaccine and pneumonia vaccine in the past.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dysphagia, Dyspnoea, Glossitis, Lip disorder
Clinical narrative: To ED at 4:49 pm. C/O difficulty swallowing, "itchy" tongue, lips feel funny, short of breath, chest tight. Medical tx with BENADRYL 50 mg IV. VSS lung without wheezes or rales. Heart reg rate and rhythm. D/C after reaction subsided. Did not drive herself home.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Hypotonia, Injected limb mobility decreased
Clinical narrative: Approx 2 - 3 min after giving HOV #2 vaccine in the left arm child states he could not move his left arm, left arm flaccid, after about 5 min child was able to move his arm.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN4, IPV, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pediatric patient given ZOSTAVAX in place of VZV as booster dose. No adverse reaction as of 10/18/13. No adverse reaction as of 10/21/13.