chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 08-AUG-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J009788, expiration date 17-MAR-2016)(dose, route, were not reproted). No adverse effect was reported. The outcome of events reproted was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 years old adolescent patient and unknown gender. On 10-SEP-2014 the patient was vaccinated with first dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPV, HEP, HEPA
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage of product in a patient who received PEDIARIX. Co-suspect products included KINRIX, HAVRIX, ENGERIX B, ROTARIX and INFANRIX. On an unknown date, the patient received PEDIARIX at an unknown dose, KINRIX at an unknown dose, HAVRIX at an unknown dose, ENGERIX B at an unknown dose, ROTARIX at an unknown dose and INFANRIX at an unknown dose. On an unknown date, an unknown time after receiving PEDIARIX, KINRIX, HAVRIX, ENGERIX B, ROTARIX and INFANRIX, the patient experienced incorrect storage of product. On an unknown date, the outcome of the incorrect storage of product was unknown. It was unknown if the reporter considered the incorrect storage of product to be related to PEDIARIX, KINRIX, HAVRIX, ENGERIX B, ROTARIX  and INFANRIX. Additional information received: The reporter noted there was a spike of temperature on July 29th 2014 in the refrigerator. The temperature was recorded as 47.5 degrees F. She had the following vaccines: PEDIARIX, KINRIX, HAVRIX, ENGERIX B, ROTARIX and INFANRIX. The vaccines were all used in patients and the supply is now exhausted. No lot numbers or other relevant information about this administration was available. She was calling to get a letter from GSK MI that the vaccines were ok to give, despite the temperature increase. No other information was available at time of report.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. The patients medical history and current conditions were not reported. On an unknown date the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (strength, dose and frequency unknown) (Lot # and expiry date not provided). No adverse events were reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter and linked with case # 1411USA008320. 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 nurse refers to an unspecified number of patients. The patients medical history and current conditions were not reported. On an unknown date the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (strength, dose and frequency unknown) (Lot # and expiry date not provided). No adverse events were reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter and linked to case # 1411USA009296. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 30-OCT-2014 the patient was vaccinated subcutaneously with an expired dose of ZOSTAVAX (0.65ml, lot # J004269, expiration date 12-JUL-2014). No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 0.39
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received KINRIX (batch number AC20B235AA, expiry date 15th January 2015). On 29th September 2014, the patient received KINRIX. On 29th September 2014, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the appropriate age at vaccine administration to be related to KINRIX. Additional information: A dose of KINRIX was given to a 4 month old baby. KINRIX was recommended for children from 4 to 6 years. No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with (Oka/Merck) VARIVAX (dose, route, lot# and expiration date were not reported) that were exposed to unsupported temperature conditions. No adverse experience had been observed or reported by any of the patients who received these improperly-stored doses. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 69 year old male patient. Patient's pertinent medical history and drug allergies were not reported. On 15-NOV-2014 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml (lot # K009874, expiry date: 19-MAR-2016), intramuscular in the right arm (reported as age appropriate vaccination after 65 years of age). Concomitant medications were not reported. In November 2014 (on an unspecified date), patient stated that his right arm was very painful and had redness and swelling from the deltoid injection site down to the elbow of his right arm after the administration of PNEUMOVAX 23. On an unspecified date, the patient was treated with non-steroidal anti-inflammatories. Outcome of the events was reported as not recovered. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with ZOSTAVAX (dose, route, lot# and expiration date were not reported) that were exposed to unsupported temperature conditions. No adverse experience had been observed or reported by any of the patients who received these improperly-stored doses. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with PROQUAD (Merck) (dose, route, lot# and expiration date were not reported) that were exposed to unsupported temperature conditions. No adverse experience had been observed or reported by any of the patients who received these improperly-stored doses. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a 21-year-old male patient who received HAVRIX (batch number AHAVB597AA, expiry date 6th September 2014). On 16th September 2014, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to HAVRIX. Additional information received: On 16 September 2014, 21 years old patient who received an expired vaccine (06 September 2014).
Age: 1.04
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash starting two days s/p vaccine increasing over week.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 24-OCT-2014, the patient was inadvertently vaccinated with a expired dose of M-M-R II expiry date 18-OCT-2014 (dose, route and lot number were not reported). No adverse effects reported. Concomitant medications was not provided. The outcome of expired M-M-R II on 10/18/2014 was inadvertently administered to a patient on 10/24/2014 was unknown. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Abscess, Blister, Cellulitis, Injection site erythema, Injection site mass
Clinical narrative: Pt. reported redness, lump, swelling at inj. site 11/10. Sought treatment from Dr 11/12/14. Dx cellulitis w/ abscess. Treated with inj and oral antibiotics. Evening of 12th, eruption of zoster blisters on (R) foot. Sought treatment from Dr 11/19/14.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Pt. reported redness, lump, swelling at inj. site 11/10. Sought treatment from Dr 11/12/14. Dx cellulitis w/ abscess. Treated with inj and oral antibiotics. Evening of 12th, eruption of zoster blisters on (R) foot. Sought treatment from Dr 11/19/14.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 12-NOV-2014, the patient was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneous that underwent a temperature excursion. No adverse effect was reported. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever max 100.4 for 1 day.
Age: 1.39
Sex: M
Vaccine: DTAP
Symptoms: Ear infection, Injection site erythema
Clinical narrative: This case was reported by a other health professional and described the occurrence of injection site redness in a 15-month-old male patient who received INFANRIX (batch number 75H53, expiry date 27th September 2016). On 6th October 2014, the patient received INFANRIX .5 ml. On 8th October 2014, 2 days after receiving INFANRIX, the patient experienced injection site redness. On an unknown date, the patient experienced left ear infection. The patient was treated with BENADRYL and BACTRIM. On an unknown date, the outcome of the injection site redness and left ear infection were not recovered/not resolved. It was unknown if the reporter considered the injection site redness and left ear infection to be related to INFANRIX.
Age: 0.26
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by the patient mother and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received KINRIX. In June 2014, the patient received KINRIX. In June 2014, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to KINRIX. Additional information: The patient received a dose of KINRIX vaccine when he was 4 month old. The patient mother believed that the vaccine was given in June 2014. KINRIX was recommended for children from 4 to 6 years.
Age: 0.3
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccination in a 4-month-old male patient who received KINRIX (batch number AC20B221BC, expiry date 25th October 2014). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccination. On an unknown date, the outcome of the inappropriate age at vaccination was unknown. It was unknown if the reporter considered the inappropriate age at vaccination to be related to KINRIX. Additional information: A dose of KINRIX was inadvertently administered to a 4 month old patient. Meanwhile KINRIX was recommended for children between 4 to 6 years. No adverse event was reported.
Sex: U
Vaccine: HEP, HEPA, HEPAB
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of wrong vaccine administered in a patient who received TWINRIX. Co-suspect products included HAVRIX and ENGERIX B. On an unknown date, the patient received the 1st dose of TWINRIX, the 2nd dose of HAVRIX and the 2nd dose of ENGERIX B. On an unknown date, an unknown time after receiving TWINRIX, HAVRIX and ENGERIX B, the patient experienced wrong vaccine administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the wrong vaccine administered and inappropriate schedule of vaccine administered were unknown. It was unknown if the reporter considered the wrong vaccine administered and inappropriate schedule of vaccine administered to be related to TWINRIX, HAVRIX and ENGERIX B. Additional information: It was an incorrect schedule for TWINRIX. Wrong vaccines given: ENGERIX B and HAVRIX. The patient received TWINRIX as dose 1 and ENGERIX B and HAVRIX as dose 2. No adverse event reported.
Age: 0.2
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received KINRIX (batch number 935RF, expiry date 17th September 2015). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration and wrong vaccine administered to be related to KINRIX. Additional information received: Vaccine administered to a 2 months old infant. No symptoms were reported.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received INFANRIX for an unknown indication. On an unknown date, the patient received INFANRIX at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the wrong vaccine administered and inappropriate age at vaccine administration to be related to INFANRIX. Additional information received: INFANRIX was inadvertently administered to a 12 years old patient instead of BOOSTRIX.
Sex: M
Vaccine: TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect product storage in a adult male patient who received BOOSTRIX (batch number 4EK53, expiry date 7th November 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown. It was unknown if the reporter considered the incorrect product storage to be related to BOOSTRIX. Additional informations received: BOOSTRIX stored below recommended temperature ranges (-0.5 C) to a male adult patient. No more specific patient information.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of expired vaccine used in a female patient who received HAVRIX (batch number AHAVB597BA, expiry date 6th September 2014). On an unknown date, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to HAVRIX. Additional information received: Patient received an expired dose of HAVRIX (06 September 2014).
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Balance disorder, Cellulitis, Chills, Injection site erythema, Injection site streaking
Clinical narrative: Initial unsolicited report was received on 10 November 2014 from a non healthcare professional. A 71 year-old female patient had on 11 October 2014 an intramuscular left deltoid injection of FLUZONE HIGH DOSE (lot number U5022AA) and a subcutaneous right arm injection of PNEUMOVAX 23 (lot number J013344) and one day later on 12 October 2014, experienced swelling, redness, fever at injection site and a knot. The patient also reported night sweats, balance issues, muscle pain and fever. The patient was evaluated by a physician and was diagnosed with cellulitis. Treatment included an "antibiotic and steroid shot". Concomitant medications included Anastrazole and Citalopram. The patient had no specified illness at the time of vaccination and pre-existing conditions were "none reported". The patient continued to have a knot on her arm as of 01 November 2014. Outcome was reported as recovered "better after 17 October 2014." Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Night sweats, Pyrexia
Clinical narrative: Initial unsolicited report was received on 10 November 2014 from a non healthcare professional. A 71 year-old female patient had on 11 October 2014 an intramuscular left deltoid injection of FLUZONE HIGH DOSE (lot number U5022AA) and a subcutaneous right arm injection of PNEUMOVAX 23 (lot number J013344) and one day later on 12 October 2014, experienced swelling, redness, fever at injection site and a knot. The patient also reported night sweats, balance issues, muscle pain and fever. The patient was evaluated by a physician and was diagnosed with cellulitis. Treatment included an "antibiotic and steroid shot". Concomitant medications included Anastrazole and Citalopram. The patient had no specified illness at the time of vaccination and pre-existing conditions were "none reported". The patient continued to have a knot on her arm as of 01 November 2014. Outcome was reported as recovered "better after 17 October 2014." Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Balance disorder, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report was received on 10 November 2014 from a non healthcare professional. A 71 year-old female patient had on 11 October 2014 an intramuscular left deltoid injection of FLUZONE HIGH DOSE (lot number U5022AA) and a subcutaneous right arm injection of PNEUMOVAX 23 (lot number J013344) and one day later on 12 October 2014, experienced swelling, redness, fever at injection site and a knot. The patient also reported night sweats, balance issues, muscle pain and fever. The patient was evaluated by a physician and was diagnosed with cellulitis. Treatment included an "antibiotic and steroid shot". Concomitant medications included Anastrazole and Citalopram. The patient had no specified illness at the time of vaccination and pre-existing conditions were "none reported". The patient continued to have a knot on her arm as of 01 November 2014. Outcome was reported as recovered "better after 17 October 2014." Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Muscle disorder, Night sweats, Pyrexia
Clinical narrative: Initial unsolicited report was received on 10 November 2014 from a non healthcare professional. A 71 year-old female patient had on 11 October 2014 an intramuscular left deltoid injection of FLUZONE HIGH DOSE (lot number U5022AA) and a subcutaneous right arm injection of PNEUMOVAX 23 (lot number J013344) and one day later on 12 October 2014, experienced swelling, redness, fever at injection site and a knot. The patient also reported night sweats, balance issues, muscle pain and fever. The patient was evaluated by a physician and was diagnosed with cellulitis. Treatment included an "antibiotic and steroid shot". Concomitant medications included Anastrazole and Citalopram. The patient had no specified illness at the time of vaccination and pre-existing conditions were "none reported". The patient continued to have a knot on her arm as of 01 November 2014. Outcome was reported as recovered "better after 17 October 2014." Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Balance disorder, Cellulitis, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Initial unsolicited report was received on 10 November 2014 from a non healthcare professional. A 71 year-old female patient had on 11 October 2014 an intramuscular left deltoid injection of FLUZONE HIGH DOSE (lot number U5022AA) and a subcutaneous right arm injection of PNEUMOVAX 23 (lot number J013344) and one day later on 12 October 2014, experienced swelling, redness, fever at injection site and a knot. The patient also reported night sweats, balance issues, muscle pain and fever. The patient was evaluated by a physician and was diagnosed with cellulitis. Treatment included an "antibiotic and steroid shot". Concomitant medications included Anastrazole and Citalopram. The patient had no specified illness at the time of vaccination and pre-existing conditions were "none reported". The patient continued to have a knot on her arm as of 01 November 2014. Outcome was reported as recovered "better after 17 October 2014." Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Injection site warmth, Myalgia, Night sweats, Pyrexia
Clinical narrative: Initial unsolicited report was received on 10 November 2014 from a non healthcare professional. A 71 year-old female patient had on 11 October 2014 an intramuscular left deltoid injection of FLUZONE HIGH DOSE (lot number U5022AA) and a subcutaneous right arm injection of PNEUMOVAX 23 (lot number J013344) and one day later on 12 October 2014, experienced swelling, redness, fever at injection site and a knot. The patient also reported night sweats, balance issues, muscle pain and fever. The patient was evaluated by a physician and was diagnosed with cellulitis. Treatment included an "antibiotic and steroid shot". Concomitant medications included Anastrazole and Citalopram. The patient had no specified illness at the time of vaccination and pre-existing conditions were "none reported". The patient continued to have a knot on her arm as of 01 November 2014. Outcome was reported as recovered "better after 17 October 2014." Documents held by sender: none.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Abnormal product of conception, Abortion spontaneous, Exposure during pregnancy, Foetal disorder, Laboratory test abnormal
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. In September 2012 the patient's mother was vaccinated with VARIVAX (Merck). No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient's mother became pregnant with an LMP of 29-OCT-2012 and an EDD of 05-AUG-13. The patient's mother was seen in office on 07-DEC-2012 to confirm if she was pregnant. The patient's mother was exposed to VARIVAX (Merck) during trimester 1. Reporting physician stated that the pregnancy ended in a miscarriage at 6 weeks (approximately in 10-DEC-2012). There was a notation in the patient's mother's chart about a D and C (dilation and curettage) taking place in January 2013. On an unknown date testing was done on products of conception and a trisomy 21 indicator was found (congenital anomaly, death). The physician stated he felt that VARIVAX (Merck) did not contribute to the miscarriage, the patient's mother's age and trisomy 21 issue, was more of an issue. The outcome of trisomy 21 issue with fetus was reported as fatal. Causality assessment was not provided. The case is linked to 1212USA003695 (parent-child link). Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Pregnancy test positive, Ultrasound antenatal screen abnormal, Uterine dilation and curettage
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. In September 2012 the patient's mother was vaccinated with VARIVAX (Merck). No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient's mother became pregnant with an LMP of 29-OCT-2012 and an EDD of 05-AUG-13. The patient's mother was seen in office on 07-DEC-2012 to confirm if she was pregnant. The patient's mother was exposed to VARIVAX (Merck) during trimester 1. Reporting physician stated that the pregnancy ended in a miscarriage at 6 weeks (approximately in 10-DEC-2012). There was a notation in the patient's mother's chart about a D and C (dilation and curettage) taking place in January 2013. On an unknown date testing was done on products of conception and a trisomy 21 indicator was found (congenital anomaly, death). The physician stated he felt that VARIVAX (Merck) did not contribute to the miscarriage, the patient's mother's age and trisomy 21 issue, was more of an issue. The outcome of trisomy 21 issue with fetus was reported as fatal. Causality assessment was not provided. The case is linked to 1212USA003695 (parent-child link). Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal death, Foetal disorder, Ultrasound antenatal screen abnormal
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. In September 2012 the patient's mother was vaccinated with VARIVAX (Merck). No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient's mother became pregnant with an LMP of 29-OCT-2012 and an EDD of 05-AUG-13. The patient's mother was seen in office on 07-DEC-2012 to confirm if she was pregnant. The patient's mother was exposed to VARIVAX (Merck) during trimester 1. Reporting physician stated that the pregnancy ended in a miscarriage at 6 weeks (approximately in 10-DEC-2012). There was a notation in the patient's mother's chart about a D and C (dilation and curettage) taking place in January 2013. On an unknown date testing was done on products of conception and a trisomy 21 indicator was found (congenital anomaly, death). The physician stated he felt that VARIVAX (Merck) did not contribute to the miscarriage, the patient's mother's age and trisomy 21 issue, was more of an issue. The outcome of trisomy 21 issue with fetus was reported as fatal. Causality assessment was not provided. The case is linked to 1212USA003695 (parent-child link). Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Uterine dilation and curettage
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. In September 2012 the patient's mother was vaccinated with VARIVAX (Merck). No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient's mother became pregnant with an LMP of 29-OCT-2012 and an EDD of 05-AUG-13. The patient's mother was seen in office on 07-DEC-2012 to confirm if she was pregnant. The patient's mother was exposed to VARIVAX (Merck) during trimester 1. Reporting physician stated that the pregnancy ended in a miscarriage at 6 weeks (approximately in 10-DEC-2012). There was a notation in the patient's mother's chart about a D and C (dilation and curettage) taking place in January 2013. On an unknown date testing was done on products of conception and a trisomy 21 indicator was found (congenital anomaly, death). The physician stated he felt that VARIVAX (Merck) did not contribute to the miscarriage, the patient's mother's age and trisomy 21 issue, was more of an issue. The outcome of trisomy 21 issue with fetus was reported as fatal. Causality assessment was not provided. The case is linked to 1212USA003695 (parent-child link). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV, MMR
Symptoms: Inappropriate schedule of drug administration, Measles post vaccine, Nasopharyngitis, Pyrexia, Rash generalised
Clinical narrative: This spontaneous report was received from a patient's mother and referred to 12 month old female patient with acid reflux. The patient received unspecified Influenza vaccine (reported as "the FLU vaccine") on 30-OCT-2014 (reported as "just a week before she received M-M-R II"). On 07-NOV-2014, the patient was vaccinated with M-M-R II (lot #, expiration date, strength, dose and frequency were not reported) injection. Concomitant therapies included hydrocortisone (manufacturer unknown) and econazole nitrate. On 09-NOV-2014 (reported as "two days after the vaccination was given") started symptoms of red, watery eyes and rash (it was reported that the "rash looked as if the patient had been burned by something") that was going down patient's leg. On 11-NOV-2014, the patient developed a cold. The reporter stated that the patient had normal cold-like symptoms including a runny nose and coughing. At that time the patient did not have a fever. On 14-NOV-2014, the patient then developed a fever of about 102 degrees which lasted till 16-NOV-2014 (duration also reproted as "during the whole weekend"). On 18-NOV-2014 The patient was diagnosed with "measles subsequent vaccination". The patient sought medical attention and attended to office visit. The patient was treated with MOTRIN and TYLENOL. No lab diagnostics were performed. The outcome of the event of measles subsequent vaccination was unknown at the time of the report. Relatedness between event of measles subsequent vaccination and M-M-R II was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV, MMR
Symptoms: Stomatitis, Upper respiratory tract infection
Clinical narrative: This spontaneous report was received from a patient's mother and referred to 12 month old female patient with acid reflux. The patient received unspecified Influenza vaccine (reported as "the FLU vaccine") on 30-OCT-2014 (reported as "just a week before she received M-M-R II"). On 07-NOV-2014, the patient was vaccinated with M-M-R II (lot #, expiration date, strength, dose and frequency were not reported) injection. Concomitant therapies included hydrocortisone (manufacturer unknown) and econazole nitrate. On 09-NOV-2014 (reported as "two days after the vaccination was given") started symptoms of red, watery eyes and rash (it was reported that the "rash looked as if the patient had been burned by something") that was going down patient's leg. On 11-NOV-2014, the patient developed a cold. The reporter stated that the patient had normal cold-like symptoms including a runny nose and coughing. At that time the patient did not have a fever. On 14-NOV-2014, the patient then developed a fever of about 102 degrees which lasted till 16-NOV-2014 (duration also reproted as "during the whole weekend"). On 18-NOV-2014 The patient was diagnosed with "measles subsequent vaccination". The patient sought medical attention and attended to office visit. The patient was treated with MOTRIN and TYLENOL. No lab diagnostics were performed. The outcome of the event of measles subsequent vaccination was unknown at the time of the report. Relatedness between event of measles subsequent vaccination and M-M-R II was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV, MMR
Symptoms: Cough, Injection site rash, Lacrimation increased, Measles post vaccine, Nasopharyngitis
Clinical narrative: This spontaneous report was received from a patient's mother and referred to 12 month old female patient with acid reflux. The patient received unspecified Influenza vaccine (reported as "the FLU vaccine") on 30-OCT-2014 (reported as "just a week before she received M-M-R II"). On 07-NOV-2014, the patient was vaccinated with M-M-R II (lot #, expiration date, strength, dose and frequency were not reported) injection. Concomitant therapies included hydrocortisone (manufacturer unknown) and econazole nitrate. On 09-NOV-2014 (reported as "two days after the vaccination was given") started symptoms of red, watery eyes and rash (it was reported that the "rash looked as if the patient had been burned by something") that was going down patient's leg. On 11-NOV-2014, the patient developed a cold. The reporter stated that the patient had normal cold-like symptoms including a runny nose and coughing. At that time the patient did not have a fever. On 14-NOV-2014, the patient then developed a fever of about 102 degrees which lasted till 16-NOV-2014 (duration also reproted as "during the whole weekend"). On 18-NOV-2014 The patient was diagnosed with "measles subsequent vaccination". The patient sought medical attention and attended to office visit. The patient was treated with MOTRIN and TYLENOL. No lab diagnostics were performed. The outcome of the event of measles subsequent vaccination was unknown at the time of the report. Relatedness between event of measles subsequent vaccination and M-M-R II was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV, MMR
Symptoms: Ocular hyperaemia, Pyrexia, Rhinorrhoea
Clinical narrative: This spontaneous report was received from a patient's mother and referred to 12 month old female patient with acid reflux. The patient received unspecified Influenza vaccine (reported as "the FLU vaccine") on 30-OCT-2014 (reported as "just a week before she received M-M-R II"). On 07-NOV-2014, the patient was vaccinated with M-M-R II (lot #, expiration date, strength, dose and frequency were not reported) injection. Concomitant therapies included hydrocortisone (manufacturer unknown) and econazole nitrate. On 09-NOV-2014 (reported as "two days after the vaccination was given") started symptoms of red, watery eyes and rash (it was reported that the "rash looked as if the patient had been burned by something") that was going down patient's leg. On 11-NOV-2014, the patient developed a cold. The reporter stated that the patient had normal cold-like symptoms including a runny nose and coughing. At that time the patient did not have a fever. On 14-NOV-2014, the patient then developed a fever of about 102 degrees which lasted till 16-NOV-2014 (duration also reproted as "during the whole weekend"). On 18-NOV-2014 The patient was diagnosed with "measles subsequent vaccination". The patient sought medical attention and attended to office visit. The patient was treated with MOTRIN and TYLENOL. No lab diagnostics were performed. The outcome of the event of measles subsequent vaccination was unknown at the time of the report. Relatedness between event of measles subsequent vaccination and M-M-R II was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles, Pain
Clinical narrative: Redness, swelling, itching at injection site.  Spread to include large are of forearm over next three days. By day 3 tiny "blisters" appeared near injection site. Generalized achiness for two days.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Redness, swelling, itching at injection site.  Spread to include large are of forearm over next three days. By day 3 tiny "blisters" appeared near injection site. Generalized achiness for two days.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Peripheral swelling, Pruritus
Clinical narrative: Redness, swelling, itching at injection site.  Spread to include large are of forearm over next three days. By day 3 tiny "blisters" appeared near injection site. Generalized achiness for two days.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Redness, swelling, itching at injection site.  Spread to include large are of forearm over next three days. By day 3 tiny "blisters" appeared near injection site. Generalized achiness for two days.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Redness, swelling, itching at injection site.  Spread to include large are of forearm over next three days. By day 3 tiny "blisters" appeared near injection site. Generalized achiness for two days.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Hyperventilation, Respiratory rate decreased, Urticaria
Clinical narrative: Face reddened; breathing was heavy and slower; one hive on face; called Dr.; drove to pharmacy for Benadryl, symptoms of allergic reaction subsided within about 30 minutes.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Fatigue, Injection site injury, Injection site pain, Malaise
Clinical narrative: (1) Severe pain in left shoulder and arm, radiating to wrist; (2) fever (99.8F-101.9F); (3) fatigue, malaise. Symptoms have continued with increasing severity for 2+ weeks since vaccination. Possible bursitis in L shoulder resultant from injection site injury to sub-deltoid bursa.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Pyrexia
Clinical narrative: (1) Severe pain in left shoulder and arm, radiating to wrist; (2) fever (99.8F-101.9F); (3) fatigue, malaise. Symptoms have continued with increasing severity for 2+ weeks since vaccination. Possible bursitis in L shoulder resultant from injection site injury to sub-deltoid bursa.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Joint range of motion decreased, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: Soreness in shoulder muscle and joint near site around 7 hours after. 4 hours after that has increased to sever pain in shoulder from any movement as well as decreased range of motion. Yet I have little feeling in my skin up to 6 inches from the site. Also have a low grade fever and body aches.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Soreness in shoulder muscle and joint near site around 7 hours after. 4 hours after that has increased to sever pain in shoulder from any movement as well as decreased range of motion. Yet I have little feeling in my skin up to 6 inches from the site. Also have a low grade fever and body aches.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injected limb mobility decreased, Pyrexia, Renal pain
Clinical narrative: Can barely move my arm where injection was administered.  Severe chills, kidneys hurt and low fever.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain
Clinical narrative: Weakness in arm, ache, hard time picking up items, pincher response not there. Motrin tid.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Asthenia, Chills, Decreased appetite, Feeling abnormal, Hyperhidrosis
Clinical narrative: Started feeling "bad" with "knots and swelling" at injection sites in right shoulder. Had "chills and sweats" no "energy" or "appetite". Ran a fever from 101 to 103 over the next 48 hours.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site nodule, Injection site swelling, Pyrexia
Clinical narrative: Started feeling "bad" with "knots and swelling" at injection sites in right shoulder. Had "chills and sweats" no "energy" or "appetite". Ran a fever from 101 to 103 over the next 48 hours.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Rash on torso, legs.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Pain, Pain in extremity
Clinical narrative: Symptoms began shortly after receiving vaccine.  Stomach began to hurt, achy feeling.  Following day c/o noticeably sore arm, ? low grade fever, then diarrhea, legs aching, and stomach "churning.
Age: 14.0
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Cerebrovascular accident
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 14 year old male patient. No information about concurrent conditions, medical history or concomitant therapy was provided. On an unknown date the patient started therapy with GARDASIL (route, dose, frequency and lot # not reported). It was reported that the patient was scheduled to receive his second dose of GARDASIL on 07-NOV-2014. On 07-NOV-2014, during the office visit the patient was vaccinated with the second dose of GARDASIL (route, dose, frequency and lot # not reported). Other suspect therapies included influenza virus vaccine (unspecified) (also reported as FLU) given on 07-NOV-2014 (also reported as on the same day). On 13-NOV-2014 the patient had a stroke. The outcome of stroke and relatedness between stroke and GARDASIL were not reported. Upon internal review stroke was determined to be medically significant. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Cellulitis, Discomfort, Erythema, Injection site pain, Limb discomfort
Clinical narrative: This is a spontaneous report from a contactable registered nurse who reported on behalf of a physician. This is second of two reports. A 40-year-old female patient while she was in dialysis clinic received PREVNAR 13 (Lot J90092; Expiration date May 2016; NDC number: 0005197105), intramuscular in right arm on 11Nov2014 approximately 7am at 0.5 ml, single. Medical history included HIV, chronic renal failure and hypertensive, all ongoing. Patient had a catheter in her left arm where she received dialysis. Concomitant medication included PNEUMOVAX 23 (lot K007773 expiry date May2015) on 11Nov2014 in right arm, amlodipine 10mg daily, carvedilol 6.25mg twice a day, lamivudine 150mg daily, ondansetron 4mg as needed, RENVELA three pills of 800mg, four times a day, warfarin 5mg 3 times a week (Tues/Thur/Sat) and 7.5mg 4 times a week (Mon/Wed/Fri/Sun), tramadol 50mg three times a day and zidovudine 300mg daily. She experienced pain with administration of the injection. On 13Nov2014 patient complained of discomfort and cellulitis located below her right elbow. She has applied for Medicaid, but has been denied. Always on 13Nov2014 she developed pain, tenderness, redness, swelling and warmness all in right arm. The outcome of discomfort was unknown, the other events recovered on unknown date.
Age: 40.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Local swelling, Pain in extremity, Skin warm, Tenderness
Clinical narrative: This is a spontaneous report from a contactable registered nurse who reported on behalf of a physician. This is second of two reports. A 40-year-old female patient while she was in dialysis clinic received PREVNAR 13 (Lot J90092; Expiration date May 2016; NDC number: 0005197105), intramuscular in right arm on 11Nov2014 approximately 7am at 0.5 ml, single. Medical history included HIV, chronic renal failure and hypertensive, all ongoing. Patient had a catheter in her left arm where she received dialysis. Concomitant medication included PNEUMOVAX 23 (lot K007773 expiry date May2015) on 11Nov2014 in right arm, amlodipine 10mg daily, carvedilol 6.25mg twice a day, lamivudine 150mg daily, ondansetron 4mg as needed, RENVELA three pills of 800mg, four times a day, warfarin 5mg 3 times a week (Tues/Thur/Sat) and 7.5mg 4 times a week (Mon/Wed/Fri/Sun), tramadol 50mg three times a day and zidovudine 300mg daily. She experienced pain with administration of the injection. On 13Nov2014 patient complained of discomfort and cellulitis located below her right elbow. She has applied for Medicaid, but has been denied. Always on 13Nov2014 she developed pain, tenderness, redness, swelling and warmness all in right arm. The outcome of discomfort was unknown, the other events recovered on unknown date.
Age: 49.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Discomfort, Erythema, Injection site cellulitis, Injection site pain, Local swelling
Clinical narrative: This is a spontaneous report from a contactable registered nurse who reported on behalf of a physician. This is first of two reports. A 49-year-old male patient received while he was in the dialysis clinic, a dose of PREVNAR 13 (Lot J90092; Expiration date May 2016; NDC number 005197105), intramuscular in right arm on 11Nov2014 approximately 7 am at 0.5 ml single. He was diabetic, had high blood pressure, high cholesterol and chronic renal failure. He had a catheter in his left arm for dialysis. Concomitant medication included PNEUMOVAX 23 (lot K007773; expiry date of May2015) administered on 11Nov2014 in right arm, aspirin at 81 mg daily, FLONASE as needed, clopidogrel at 75mg daily, carvedilol at 12.5mg twice a day, lisinopril 20mg daily, pantoprazole 40mg daily, pravastatin 40mg at bedtime, LANTUS on a sliding scale, vancomycin 1g IV for planned shunt placement and VELPHORO 500mg four times a day. On 13Nov2014 patient complained of severe pain during administration of PREVNAR 13 and discomfort. On the same date he experienced cellulitis of arm: cellulitis was above his right elbow and did not require an emergency room visit. Always on 13Nov2014 patient had pain and tenderness in right arm and redness, swelling and warm of right arm. The outcome of discomfort was unknown, the other events recovered on unknown date.