chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Autoimmune disorder, Contusion, Epistaxis, Haematocrit normal, Haemoglobin normal
Clinical narrative: Initial information received from a consumer who is the parent on 03 February 2014. A 3 year old female patient, with a medical history of eczema, received FLUZONE QIV, batch U4769AA, on 10 January 2014, route and site of administration were not reported. The reporter denied that the patient had an illness at the time of vaccination or any other vaccinations with 4 weeks of FLUZONE QIV. A couple of days later, the patient experienced a low grade fever. On 18 January 2014, the patient presented with bleeding from the nose, mouth and had bruises and petechiae. Platelet count was 1000 units on an unreported date. The patient was taken to the emergency room and was hospitalized for two days, dates not reported. The patient was treated with IG. The reporter stated it was autoimmune origin. On an unreported date, the platelet level was 33,000. The patient was followed by hematology. No other medications were given. The patient outcome was not recovered. Follow-up information was received from the healthcare professional on 27 March 2014, which included laboratory reports and the patient's complete vaccination record. Abnormal laboratory findings on 17 February 2014 included the following: red blood cell count 3.85 mill/mol; hemoglobin 11.0 g/dL and hematocrit 32.6%. Additionally, platelet count was 144 thous/mcL. Outcome was not reported. Follow-up information was received on 02 May 2014 from a healthcare professional. The patient's birth weight was 7 pounds and she has one brother and one sister. The patient's platelet count of 1,000 was detected on 18 January 2014 (previously was not reported). The patient no longer receives treatment. Outcome was recovered. Documents held by sender: office records, including complete vaccination record and laboratory report.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Immunoglobulin therapy, Measles antibody, Mouth haemorrhage, Mumps antibody test, Petechiae
Clinical narrative: Initial information received from a consumer who is the parent on 03 February 2014. A 3 year old female patient, with a medical history of eczema, received FLUZONE QIV, batch U4769AA, on 10 January 2014, route and site of administration were not reported. The reporter denied that the patient had an illness at the time of vaccination or any other vaccinations with 4 weeks of FLUZONE QIV. A couple of days later, the patient experienced a low grade fever. On 18 January 2014, the patient presented with bleeding from the nose, mouth and had bruises and petechiae. Platelet count was 1000 units on an unreported date. The patient was taken to the emergency room and was hospitalized for two days, dates not reported. The patient was treated with IG. The reporter stated it was autoimmune origin. On an unreported date, the platelet level was 33,000. The patient was followed by hematology. No other medications were given. The patient outcome was not recovered. Follow-up information was received from the healthcare professional on 27 March 2014, which included laboratory reports and the patient's complete vaccination record. Abnormal laboratory findings on 17 February 2014 included the following: red blood cell count 3.85 mill/mol; hemoglobin 11.0 g/dL and hematocrit 32.6%. Additionally, platelet count was 144 thous/mcL. Outcome was not reported. Follow-up information was received on 02 May 2014 from a healthcare professional. The patient's birth weight was 7 pounds and she has one brother and one sister. The patient's platelet count of 1,000 was detected on 18 January 2014 (previously was not reported). The patient no longer receives treatment. Outcome was recovered. Documents held by sender: office records, including complete vaccination record and laboratory report.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Platelet count decreased, Pyrexia, Red blood cell count decreased, Rubella antibody test
Clinical narrative: Initial information received from a consumer who is the parent on 03 February 2014. A 3 year old female patient, with a medical history of eczema, received FLUZONE QIV, batch U4769AA, on 10 January 2014, route and site of administration were not reported. The reporter denied that the patient had an illness at the time of vaccination or any other vaccinations with 4 weeks of FLUZONE QIV. A couple of days later, the patient experienced a low grade fever. On 18 January 2014, the patient presented with bleeding from the nose, mouth and had bruises and petechiae. Platelet count was 1000 units on an unreported date. The patient was taken to the emergency room and was hospitalized for two days, dates not reported. The patient was treated with IG. The reporter stated it was autoimmune origin. On an unreported date, the platelet level was 33,000. The patient was followed by hematology. No other medications were given. The patient outcome was not recovered. Follow-up information was received from the healthcare professional on 27 March 2014, which included laboratory reports and the patient's complete vaccination record. Abnormal laboratory findings on 17 February 2014 included the following: red blood cell count 3.85 mill/mol; hemoglobin 11.0 g/dL and hematocrit 32.6%. Additionally, platelet count was 144 thous/mcL. Outcome was not reported. Follow-up information was received on 02 May 2014 from a healthcare professional. The patient's birth weight was 7 pounds and she has one brother and one sister. The patient's platelet count of 1,000 was detected on 18 January 2014 (previously was not reported). The patient no longer receives treatment. Outcome was recovered. Documents held by sender: office records, including complete vaccination record and laboratory report.
Sex: U
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Pain in extremity
Clinical narrative: Initial report received on 20 NOV 2014 from a healthcare provider (nurse). It represents one of the cluster of 50 to 100 patients reported by the same reporter who each experienced adverse events following administration of FLUZONE HD (batch numbers UR4722AA and UT4721AA) The events for the other patients are captured in case numbers 2013SA22028 and 2013SA123404.  An unidentified patient was administered FLUZONE HD into the deltoid, batch numbers reported as UT47222AA and UT4621AA. The vaccination was administered during clinics sometime between 07 OCT 2013 to 20 NOV 2013. Within 24 hours the patient experienced pain from arm to wrist, headache, breathing difficulty. The patient went to the emergency department for steroids and was released. The patient was not ill at the time of vaccination. The patient is now doing well. The patient's medical history and concomitant medications were not reported. A quarter of the patiens had the FLUZONE vaccine the previous year. No further details were available at the time of this report. The patient outcome is recovered on an unreported date. Documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Urticaria
Clinical narrative: Initial report received from a non-healthcare professional on 30 JAN 2014. A patient, whose gender, age, medical history and concomitant medications was not reported had received a dose of FLUZONE Quadrivalent (batch number: 04792AA) dose, dose in series, route and site of administration were not reported on 06 JAN 2014. On 08 JAN 2014, two days after vaccination the patient developed hives all over my body. Corrective treatments and laboratory investigations were not reported. The outcome of the events was not reported. Documents held by sender: None.  Additional information was received from the consumer's husband on 30 JAN 2014, which provided contact information for her physician.  The female patient, was 62 at the time of the event, had a history of diabetes, hypertension and arthritis, with allergies in latex, penicillin, azithromycin, sulfa drugs, Nizoral, Lamisil , azasite and "possibly cortisone". Concomitant medications included a cortisone/lidocaine injection in her knee approximately one week prior to vaccination. She received an intramuscular injection of FLUZONE on 06 JAN 2014, and two days post-vaccination began experiencing generalized hives described as "red circles with white/clear centers". She developed redness of her face, neck, and chest, "possibly allergic reaction". She was seen by two physicians and prescribed diphenhydramine, doxepin, levo cetirizine, des loratadine, atrapro  gel, clobetasol propionate and triamcinolone cream. She was also instructed to avoid eggs. According to the reporter, the patient continued to experience generalized hives and further testing was planned. The patient had not recovered at the time of this report.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Initial report was reported by healthcare professional on 03- Dec-2013: A 53 year old male, medical history and concomitant medication were unknown, received dose of FLUZONE (Lot# UT4722BA) at left deltoid, on 23-Nov-2013. On 23-Nov-2013, patient experienced rash on arm which spread over entire body. Event was not resolved at the time of report. Documents held by sender: none. Follow-up information received from a healthcare professional on 16-Jan-2014: The patient had in fact received a dose of FLUZONE ID. He saw a dermatologist and, after using steroids, his rash was resolved in "2" weeks i.e. around 20-Dec-2013. Upon internal review, this case was assessed as serious, i.e. as an important medical event.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Vomiting, Weight decreased
Clinical narrative: Initial report was received on 17 October 2013 from a health care professional. A six month-old male patient with a history of GERD had received on 14 October 2013 a first dose intramuscular right thigh injection of FLUZONE QIV, lot number U4479AA; a third dose intramuscular left thigh injection of PENTACEL, lot number C4485AB and third dose intramuscular right thigh injection of PREVNAR, Pfizer lot number G57196 and on 15 October 2013 developed vomiting and had a two pound weight loss. The patient was evaluated by a physician and was admitted to the hospital on 17 October 2013 for IV fluids (not otherwise specified). The mother stated that the patient had a little cold at the time of vaccination. The patient was taking PREVACID. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Initial report received from a consumer on 23 January 2014. A 49 year-old female patient with no reported past medical history had received on 30 September 2013 a 0.5ml dose of FLUZONE QUADRIVALENT (lot number, route and site not reported) and one week later developed a 104 fever. The patient had received the "TIV vaccine for 30 years". No further information was provided at the time of the report. Outcome was not reported. Documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, RV5
Symptoms: Convulsion, Musculoskeletal stiffness, Tremor
Clinical narrative: Initial report received from a healthcare professional on 08 January 2014. A 06-month-old male patient had received FLUZONE and PENTACEL batch number, dose and anatomical site of administration were not reported intramuscularly and Rotavirus vaccine (other MFR) batch number, dose and anatomical site of administration were not reported intramuscularly on an unspecified date. Patient had no medical history and illness at the time of vaccination. Concomitant medication was not reported. On an unspecified date, 24 hours after vaccination, the patient experienced seizure, the body became stiff and was shaking. Event lasted a few seconds, and then repeated for second time. Time elapsed between episodes was unclear. Child was afebrile and had no further episodes. Corrective treatments were not reported and laboratory investigations were not performed. On an unspecified date, the patient had recovered from the event. Documents held by sender: none. Follow up information was received on 10 February 2014: On 11 December 2013, the patient received FLUZONE (batch number C4779AA, dose not reported) in right thigh, PENTACEL (batch number C4486AA; C4450AA also mentioned) on left thigh and oral ROTATEQ vaccine (batch number 0578AE). On 12 December 2013, the patient developed seizure, body became stiff and shaking. The reporter considered the events as medically significant. Follow-up information was received from the physician on 26 March 2014. The patient had been seen, and was "doing well". According to the reporter, the patient "can have all shots". No additional information was provided.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The below narrative include initial information received from a non-healthcare professional on 19 September 2013 plus subsequent follow up: A 5-year-old female patient with no reported medical history had received a dose of FLUZONE intramuscularly (site and batch number, route and site of administration not reported) on 13 September 2013. On 14 September 2013, the patient developed 100.6 degree temperature and a red raised bump under the injection site. The bump was warm to the touch and itched for one week. Laboratory investigations and treatment medications were not reported. At the time of this report, the outcome of the events were not reported. At the time of this report, the outcomes of the events were recovered. List of documents held by sender: none. Additional information received from a non-healthcare professional on 19 September 2013: Dosing information for vaccine, event start and event outcome added. Narrative and relevant field updated.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test normal, Depression, Major depression
Clinical narrative: This spontaneous report as received from a registered nurse refers to her son who was also a patient. The patient was 16 years old and male. The patient's pertinent medical history and drug allergies were none. On 21-OCT-2014, the patient was vaccinated with first dose of GARDASIL (Dose/Frequency: Unspecified and lot # not reported) intramuscularly. Concomitant therapies included BENADRYL. Approximately on 30-OCT-2014 (reported as 10 days later), the patient experienced major depressive episode and depressionary anxiety. On an unspecified date, the patient saw an unspecified psychologist in regards to the event. The unspecified psychologist prescribed ATIVAN and CELEXA for treatment. The nurse stated 25 days after starting CELEXA it was no longer working, at which time the patient discontinued using the CELEXA. The nurse reported that the patient saw the unspecified psychologist, on an unspecified date, and was then placed on EFFEXOR for treatment. The nurse stated the patient also discontinued using the ATIVAN on an unspecified date for unspecified reasons. The patient had 2 emergency visits in 2 weeks but was never actually admitted to the hospital. The patient had a Chem 20 and a tox screen both showed everything was normal. The outcome of major depressive episode and depressionary anxiety was reported as under control and the patient has not had any episodes since Thanksgiving. The causality of the events was not reported. No product quality complaint was reported for GARDASIL. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant which refers to a 62 year old male patient. On 12-DEC-2014 the patient was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX. No adverse event was reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received ENGERIX B adult. Previously administered products included ENGERIX B (Dose 1 (more than 3 months ago)). On an unknown date, the patient received the 2nd dose of ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional information received: The pharmacist reports that the patient received her  ENGERIX B dose more than 3 months ago. She is late to receive her second dose. She has not received the second dose yet. The caller did not have any other information about this adverse events.
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of wrong vaccine administered in a male patient who received ENGERIX B adult (batch number FB3A3, expiry date 28th January 2016). Previously administered products included TWINRIX (Dose 1). On 8th September 2041, the patient received ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced wrong vaccine administered. On an unkonwn date, the outcome of the wrong vaccine administered was unknown. Additional information received: A patient was started on TWINRIX on 0. 1 and 6 months schedule. He received TWINRIX at 1st dose on 05 August 2014 and then a 2nd dose on 08 September 2014 ENGERIX B was given.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Live birth
Clinical narrative: This is a prospective pregnancy case. This 32-year-old female subject was enrolled in a study. The subject received DTPa vaccine (intramuscular) on 25th June 2014. Concomitant products included Prenatal Vitamin. The subject's last menstrual period was on 26th November 2013 and estimated date of delivery was 2nd September 2014. The subject received Tdap vaccine at week 30 of the pregnancy and during the third trimester of pregnancy. On 25th June 2014, an unknown time after receiving Tdap vaccine the subject developed vaccine exposure during pregnancy (Non-serious). Additional event(s) included live birth. The outcome of vaccine exposure during pregnancy was not applicable. The outcome(s) of the additional event(s) included live birth (unknown). The pregnancy resulted in a live neonate with no apparent congenital anomaly. On 3rd September 2014 after 40 weeks and 1 day, the subject gave birth to a male neonate via vaginal delivery. The neonate weight 3635 grams (8lbs 0oz) at birth. APGAR scores were 9 and 10. It was unknown if the investigator considered the vaccine exposure during pregnancy and live birth to be related to Tdap vaccine.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy, Laboratory test normal, No adverse event, Prenatal screening test
Clinical narrative: This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 24-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history did not included any pregnancy. The subject did not use contraception. On 1 may 2014, the subject received unspecified dose of BOOSTRIX 9.5 ml, intramuscular, unknown injection site). Subject's last menstrual period was on 28 September 2013 and estimated date of delivery was on 04 July 2014. The type of conception was normal. The subject was exposed to the vaccine during the 3rd trimester. The prenatal testing showed no evidence of a defect. At the time od reporting, the pregnancy was ongoing. This was one of the 3 pregnancies received from the same reporter. Follow-up information received on 22 July 2014: Subject's details, VAERS informations and vaccine responsible physician were provided. An unspecified number of pregnant women received BOOSTRIX. Follow-up information received on 01 October 2014: This pregnancy was a normal conception. On 10 July after 41 weeks gestation, the subject gave birth to a male live infant without congenital anomaly, by normal vaginal delivery. The infant had an Apgar score of (6-9), a weight of 3.223 kg. The mother did not experienced an adverse event. Follow-up information received on 06 November 2014: The delivery date was updated from 10 July 2014 to 09 July 2014. The baby's length and head circumference at birth were not available.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 26-year-old female subject was enrolled in a study. The subject received dtpa vaccine (intramuscular) .5 ml on 22nd May 2014. The subject's past medical history included spontaneous abortion. The subject's last menstrual period was on 2nd November 2013 and estimated date of delivery was 9th August 2014. The subject received dtpa vaccine at week 28 of the pregnancy and during the third trimester of pregnancy. On 22nd May 2014, an unknown time after receiving dtpa vaccine the subject developed vaccine exposure during pregnancy (Non-serious). Additional event(s) included live birth. The outcome of vaccine exposure during pregnancy was unknown. The outcome(s) of the additional event(s) included live birth (unknown). The pregnancy resulted in a live neonate with apparent congenital anomaly. On 8th August 2014 after 39 weeks and 6 days, the subject gave birth to a male neonate via vaginal delivery. The neonate weighed 2024 grams (4lbs 7oz) at birth. APGAR scores were 8 and 9. It was unknown if the investigator considered the vaccine exposure during pregnancy and live birth to be related to dtpa vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 07-JAN-2015, the patient was administered an expired dose of ZOSTAVAX vial lot number J011826,  expiration date 26-DEC-2014 (dose number, route of administration and anatomical location were not reported). No adverse effects were reported. Additional information is not expected as the reporter did not wish follow up contact.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age who on 28-JUN-2011 was vaccinated with a first dose of GARDASIL (dose, lot #, expiration date and route were not reported) and on 06-JAN-2012 received second dose of GARDASIL (dose, lot #, expiration date and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. Information about concurrent conditions and medical history was not provided. On an unknown date the patient was vaccinated with a dose of GARDASIL, dose 0.5 ml (strength, dose number, route and lot number not provided). Co-suspect and concomitant therapies were not reported. On an unknown date, 4 days after onset of therapy, the patient experienced urticaria and an unspecified rash. The patient was examined by the physician due to the events. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 16 month old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on 23-DEC-2014, the patient was vaccinated with (Oka/Merck) VARIVAX INJ that was improperly stored (0.5 ml once, subcutaneously; lot number not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.29
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 15 month old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on 31-DEC-2014, the patient was vaccinated with VARIVAX (Merck) inj that was improperly stored (0.5 ml once, subcutaneously; lot number not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that the patients received (Oka/Merck) VARIVAX INJ that was improperly stored (0.5 ml once, subcutaneously; lot number not provided), between 12-AUG-2014 and 06-JAN-2015. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.32
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 15 month ol patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on 16-DEC-2014, the patient was vaccinated with VARIVAX (Merck) inj that was improperly stored (0.5 ml once. subcutaneously; lot number not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Dyspnoea, Fatigue, Full blood count normal, Headache
Clinical narrative: Sxs. extreme fatigue, HA, skin rash over upper (L) arm extending from distal to injection site -> elbow, which is pruritic, hyperemic. Reports episodes of SOB, and back discomfort up to 1 week post vaccination. Arthralgias.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Musculoskeletal discomfort
Clinical narrative: Sxs. extreme fatigue, HA, skin rash over upper (L) arm extending from distal to injection site -> elbow, which is pruritic, hyperemic. Reports episodes of SOB, and back discomfort up to 1 week post vaccination. Arthralgias.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 23-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 6 August 2014, the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown injection site). Her last menstrual period was on 09 January 2014 and estimated date of delivery was on 16 October 2014. The subject was exposed to the vaccines during the last trimester in 24 and 6 days of gestation. The conception was a normal one (no in-vitro fertilization used). No adverse events were reported. At the time of reporting the pregnancy was ongoing. Follow-up information received on 09 January 2015 form the nurse: The VAERS details were provided. Patient's date of birth was reported. On 03 October 2014, after 38 1/7 weeks gestation, the subject gave birth to a male live infant without congenital anomaly, by normal vaginal delivery. The infant had an Apgar score of (9-9), with a weight of 3.764 kg, length of 20 inches and a head circumference of 14.5 inches.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Fatigue, Influenza like illness, Malaise, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 64-year-old male patient who received BOOSTRIX. Concurrent medical condition included blood pressure high, cholesterol (over 200) and polycythemia vera. Concomitant products included COREG, hydroxyurea; LIPITOR and ramipril. On 5th January 2015 12:00, the patient received BOOSTRIX (injection) .5 ml. On 7th January 2015, 2 days after receiving BOOSTRIX, the patient experienced feeling unwell, general body pain, dry cough, influenza-like symptoms, fever and fatigue. On an unknown date, the outcome of the feeling unwell, general body pain, dry cough, influenza-like symptoms, fever and fatigue were recovering/resolving. The reporter considered the feeling unwell, general body pain, dry cough, influenza-like symptoms, fever and fatigue to be almost certainly related to BOOSTRIX. This was 1 of the 2 cases received from the same reporter and same family. Additional details provided: The patient reported that he started to experience adverse events on Tuesday. He reported that he felt fairly sick and like he has a low grade fever.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 64-year-old male patient who received BOOSTRIX. Concurrent medical condition included blood pressure high, cholesterol (over 200) and polycythemia vera. Concomitant products included COREG, hydroxyurea; LIPITOR and ramipril. On 5th January 2015 12:00, the patient received BOOSTRIX (injection) .5 ml. On 7th January 2015, 2 days after receiving BOOSTRIX, the patient experienced feeling unwell, general body pain, dry cough, influenza-like symptoms, fever and fatigue. On an unknown date, the outcome of the feeling unwell, general body pain, dry cough, influenza-like symptoms, fever and fatigue were recovering/resolving. The reporter considered the feeling unwell, general body pain, dry cough, influenza-like symptoms, fever and fatigue to be almost certainly related to BOOSTRIX. This was 1 of the 2 cases received from the same reporter and same family. Additional details provided: The patient reported that he started to experience adverse events on Tuesday. He reported that he felt fairly sick and like he has a low grade fever.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 17 July 2014, the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown injection site). The subject's last menstrual period was on 01 December 2013 and estimated date of delivery was on 07 September 2014. The type of conception was normal. The subject was exposed to the vaccine during the 3rd trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 18 September 2014: The subject was exposed to vaccine when she was 32 4/7 weeks of gestation. The VAERS details were provided. Follow-up information received on 05 January 2015: This pregnancy was a normal conception. After 38 2/7 weeks gestation, the subject gave birth to a male live infant without congenital anomaly, by normal vaginal delivery. The infant had an APGAR score of [9-9], a weight of 2.760 kg.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a male patient of unknown age. The patient had no pertinent medical history nor drug reactions or allergies. On 30-DEC-2014 the patient was vaccinated with PNEUMOVAX 23 lot # reported as 018528, expiration date 14-APR-2016 (strength, dose and route not provided). There was no concomitant medication. On 31-DEC-2014 the patient experienced cellulitis and swollen arm. Patient sought medical attention and unspecified antibiotics were given as a treatment by the physician. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. the pharmacist informed, that the patient received two doses of ZOSTAVAX (route, dosage, lot# and expiration date were not reported). Concomitant therapy was not reported. One dose was administered on an unknown date in 2014 (also reported as last year), and the other dose was administered on an unspecified date in 2015 (also report as this year), the pharmacist did no report adverse effects. The patient contacted the pharmacist looking for medical attention. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Cyanosis, Dizziness
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative, refers to a 15 year old male patient. Concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with a third dose of GARDASIL (dose, route, lot# and expiration date were not provided). Concomitant medication was not reported. On an unknown date, soon after administration of patient's third dose of GARDASIL, his lips turned blue and he felt faint. The patient sought medical attention in an office.  It was not known if the patient fainted or if he required medical treatment. The outcome of the events was not reported. Relatedness between the events and GARDASIL was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative regarding a female patient (age unknown). Medical history included shingles when she was approximately 30 years old. Concomitant medications were not provided. On an unspecified date, the patient received a dose of ZOSTAVAX (route and lot number not provided). She later developed shingles on an unspecified date when she was over 50 years old. The outcome of the shingles was not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient, The patient's medical history included unspecified cardiac history, back pain and itchy skin. On 25-NOV-2014 the patient was vaccinated with ZOSTAVAX lot# K012924, expiration 29-NOV-2015, 0.65ml subcutaneous. Concomitant therapies included ATARAX. It was reported that the patient developed "red bumps along her spine that itched a week after she received ZOSTAVAX, and the red bumps lasted about a week and then went away." The pharmacist did not observe "bumps" and does not know it the patient developed a rash. It was unknown of the patient informed her physician or sought medical attention. No additional information reported. Follow up information was received from the pharmacist on 17-DEC-2014. The pharmacist reported that the patient sought medical attention from her pain physician. It was reported that the pain physician could see spots that he thought could be shingles. No further information. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This spontaneous report was received from a physician refers to a 76 year old female patient without medical history, drug reactions and allergies. In approximately January 2005 the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration and lot # were not reported). On 12-JAN-2015 the patient was vaccinated with her second dose of PNEUMOVAX 23 lot # J013555, expiration date 02-MAY-2015, 0.5 ml, subcutaneous in the left arm. Concomitant therapies included nortriptyline and LIPITOR. On 14-JAN-2015 the patient experienced pain and swelling below the elbow of the arm in which the dose of PNEUMOVAX 23 was administered. The patient also reported that the area which was swollen was also itching. The physician reported that the area of redness was warm to the touch. In response to the question about significant disability or incapacity, the physician stated that the patient could not use her left arm. Physician is being to recommend to the patient, BENADRYL and ADVIL along with ice to the area that was affected. None of those treatments had been administered to the patient at the time of this report. There were no laboratory diagnostics studies performed. The outcome of the above mentioned events was reported as not recovered/not resolved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician refers to a 76 year old female patient without medical history, drug reactions and allergies. In approximately January 2005 the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration and lot # were not reported). On 12-JAN-2015 the patient was vaccinated with her second dose of PNEUMOVAX 23 lot # J013555, expiration date 02-MAY-2015, 0.5 ml, subcutaneous in the left arm. Concomitant therapies included nortriptyline and LIPITOR. On 14-JAN-2015 the patient experienced pain and swelling below the elbow of the arm in which the dose of PNEUMOVAX 23 was administered. The patient also reported that the area which was swollen was also itching. The physician reported that the area of redness was warm to the touch. In response to the question about significant disability or incapacity, the physician stated that the patient could not use her left arm. Physician is being to recommend to the patient, BENADRYL and ADVIL along with ice to the area that was affected. None of those treatments had been administered to the patient at the time of this report. There were no laboratory diagnostics studies performed. The outcome of the above mentioned events was reported as not recovered/not resolved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pruritus
Clinical narrative: This spontaneous report was received from a physician refers to a 76 year old female patient without medical history, drug reactions and allergies. In approximately January 2005 the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration and lot # were not reported). On 12-JAN-2015 the patient was vaccinated with her second dose of PNEUMOVAX 23 lot # J013555, expiration date 02-MAY-2015, 0.5 ml, subcutaneous in the left arm. Concomitant therapies included nortriptyline and LIPITOR. On 14-JAN-2015 the patient experienced pain and swelling below the elbow of the arm in which the dose of PNEUMOVAX 23 was administered. The patient also reported that the area which was swollen was also itching. The physician reported that the area of redness was warm to the touch. In response to the question about significant disability or incapacity, the physician stated that the patient could not use her left arm. Physician is being to recommend to the patient, BENADRYL and ADVIL along with ice to the area that was affected. None of those treatments had been administered to the patient at the time of this report. There were no laboratory diagnostics studies performed. The outcome of the above mentioned events was reported as not recovered/not resolved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash erythematous, Skin reaction
Clinical narrative: Patient called from physician's office on 1/19/15 to report skin reaction to vaccine given Friday. Doctor described as vesicular blisters/red raised rash. Patient came to pharmacy later and said MD says she has shingles.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The medical assistant reported that, on 31-DEC-2014, the patient was administered an expired dose of VARIVAX (Merck) inj (lot # H018794, expiration date 24-OCT-2014), 0.5 ml, subcutaneously. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an unspecified health professional (manufacturer number: 61009) refers to group of 30 patients of unknown age and gender. Patients' medical histories were not reported. On 24-NOV-2041, doses of PNEUMOVAX 23 (prefilled syringe) (lot # K010466, expiration date: 23-MAR-2016) have been exposed to temperatures outside of the required temperature range (exact temperatures and duration of exposure were not provided by the reporter). On unspecified dates, 30 patients were vaccinated with incorrectly stored doses of PNEUMOVAX 23 (prefilled syringe) (lot # K010466, expiration date: 23-MAR-2016) (doses, frequencies, routes of administration and indications were not specified). Concomitant medication were not reported. The reporter stated that to her knowledge no adverse reactions were reported to the office. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The physician reported that on 09-JUN-2014 the patient was vaccinated with a first dose of GARDASIL (dose, route of administration, lot# and expiration date were not provided). On 02-JUL-2014 the patient was vaccinated with a second dose of GARDASIL (dose, route of administration, lot# and expiration date were not provided) and on 02-DEC-2014 the patient was vaccinated with a third dose of GARDASIL (dose, route of administration, lot# and expiration date were not provided). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA, HPV4, PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to patients of unknown ages. On an unknown date the primary reporter reported that patients were vaccinated with PNEUMOVAX 23. Other suspect therapies included GARDASIL, M-M-R II, VAQTA, VARIVAX (Merck), ROTATEQ oral and RECOMBIVAX HB underwent temperature excursions. The healthcare worker reported that does were administered or how many patients. The healthcare worker stated that she will have someone call back with further information from the office that this occurred at. On an unknown date the patients experienced temperature excursions and no adverse effect. The outcome of temperature excursion and no adverse effect is unknown. The reporter considered temperature excursions to be not related to VAQTA, RECOMBIVAX HB, VARIVAX (Merck), GARDASIL, PNEUMOVAX 23 and ROTATEQ oral. Action taken with the therapy drugs were not provided. The reporter considered no adverse effect to be not related to PNEUMOVAX 23, VAQTA, VARIVAX (Merck), ROTATEQ oral, GARDASIL, and RECOMBIVAX HB. No further information was provided. Follow-up 09-Dec-2014: reported that the primary reporter is physician. The physician reported that since first week of Jun-2014, GARDASIL, VAQTA (adult formulation), and PNEUMVOAX 23 were improperly stored. Unknown number of doses were administered to unspecified patients. No adverse effects. No additional information was provided by this reporter. No additional information was provided by this reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The medical assistant reported that, on an unspecified date, the unspecified patient received a dose of VARIVAX (Merck) inj, which was improperly stored (0.5 ml, subcutaneously). No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.51
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 18 month old female patient. The patient has no relevant medical history, past drug history, concomitant medications or drug allergies. On 14-Jan-2015, the patient received a (Oka/Merck) VARIVAX (0.5 ml, subcutaneously, lot # KI005176, expiry date: 10-APR-2016) for her 18 month well baby appointment. It was reported that received vaccine had undergone a temperature excursion. The excursion that occurred was at 23 degrees Fahrenheit for up to 2.5 weeks. The patient's relevant laboratory data was unknown. The patient present status at the time of the report was not unknown. This is one of several report from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient. In Jun-1997 and AUG-2012 the patient was vaccinated with VARIVAX (Merck). On 06-DEC-2014 a panel of IgG titers drawn showed varicella virus test negative. No treatment was given. The outcome was reported as not recovered. See MARRS# 1501USA007199 for event involving MMR. This is one of 2 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of 0.5 ml VAQTA (lot # K005802, 24-OCT-2015), intramuscular which were exposed to 32.5F for 2 hours. This event was considered as incorrect product storage. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of 0.5 ml GARDASIL (lot # K004204, expiration date 12-JAN-2017), (lot # was reported as K006960, expiration date 19-FEB-2017), (lot # J015378, expiration date 09-APR-2016), (lot # K005881, expiration date 14-JAN-2017), intramuscular which were exposed to 32.5F for 2 hours. This event was considered as incorrect product storage. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old female patient. In APRIL-1996 and MAY-1999 the patient was vaccinated with M-M-R II. On 06-DEC-2014 the patient had a panel of IgG titers drawn which were negative for M-M-R II. Please see MARRS# 1412USA007855 for event involving VARIVAX. This is one of 2 reports received from the same source. Additional information has been requested.