chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare worker referring to a patient of unknown age and gender. The patient's medical history ws not reported. On 18-FEB-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 09-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 26-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 13-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 25-MAR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered
Clinical narrative: Given Pediarix and extra Hep B vaccination.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Extra doses of vaccines were given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection Site: Redness, Swollen, Itchy. No treatment.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Extra dose of vaccine given.
Age: 73.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Lymphadenopathy, Measles antibody positive, Mumps antibody test positive, Rash
Clinical narrative: Started with Rash, pain in joints, lymph node swelling, sores in her mouth. She was instructed to see her MD and did not think it was necessary until 6/25/2015 when she agreed to call MD.
Age: 73.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative, Stomatitis
Clinical narrative: Started with Rash, pain in joints, lymph node swelling, sores in her mouth. She was instructed to see her MD and did not think it was necessary until 6/25/2015 when she agreed to call MD.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 02-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Pt c/o pain at injection site with sharp pain at times more pronounced at noc.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Injection site reaction, Rash erythematous, Rash generalised
Clinical narrative: Pinpoint red rash back, chest, hairline, arms, legs. Afebrile. Lack of appetite. Referred to PCP.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching and swelling on both deltoid muscle.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: 425 pm, MD gave HPV9. Left room 5 mins later, patient in room alone on exam table. Staff heard fall, patient found on floor hit head had passed out. Juice & crackers given, patient recovered > 20 mins.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever (? how high) mother had no thermometer. She gave her MOTRIN at 7 AM on 06-25-15. Temperature returned to normal. No medical tx given by MD or ER.
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Amniotic cavity infection, Exposure during pregnancy
Clinical narrative: Initial unsolicited literature report received from healthcare professional on 18 June 2015. This case is linked to case ID's: 2015SA090249, 2015SA090258, 2015SA090259, 2015SA090257, 2015SA090261, 2015SA090262. (Same literature, reporter and event). Abstract: Background: In October 2012, the Committee recommended dose of Tdap during each pregnancy, irrespective of the woman's prior history of receiving Tdap. A retrospective cohort study to assess the safety of Tdap vaccination in pregnant women in two Vaccine Safety Datalink (VSD) sites during 2010-2012 found a small but statistically significant increased risk of chorioamnionitis. Objective: We conducted a review of the VAERS database to describe reports of chorioamnionitis following receipt of any vaccines. Methods: We searched the VAERS database for reports of chorioamnionitis after any vaccine during the period from July 1, 1990 through February 2, 2014. Results: VAERS received 31 reports of chorioamnionitis out of 3389 pregnancy reports in 24 years. The three most common vaccines in these reports were H1N1, quadrivalent human papillomavirus (HPV4), and Tdap vaccines in 32%, 29% and 26% of reports, respectively. Fifty-eight percent of reports had at least one reported risk factor for chorioamnionitis. Chorioamnionitis was identified in 3 reports of spontaneous abortions and 6 stillbirths, 6 reports of preterm birth (two of whom died) and 16 reports of term birth; maternal outcomes included two reports of postpartum hemorrhage and one report of maternal admission to the intensive care unit. No maternal deaths were reported. Conclusion: Chorioamnionitis was found to be uncommonly reported, representing 1% of pregnancy reports to VAERS. A majority of reports had at least one risk factor for chorioamnionitis. Two female patients, whose medical history and concomitant medications were not reported, had received a dose of Influenza vaccine and a dose of Tdap (batch number, route and site of administration were not reported for all vaccines) on unspecified date. On unspecified date after vaccinations, patients experienced chorioamnionitis and were pregnant during vaccination. The last menstrual period and estimated date of delivery was not reported. Pregnancy exposure timing was unknown. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: chorioamnionitis and vaccine exposure during pregnancy. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Amniotic cavity infection, Exposure during pregnancy
Clinical narrative: Initial unsolicited report received from literature on 18 June 2015. This case is linked to 2015SA090249, 2015SA090258, 2015SA090257, 2015SA090260, 2015SA090261 and 2015SA090262 (same literature, reporter and event). Abstract: Background: In October 2012, the Committee recommended dose of Tdap during each pregnancy, irrespective of the woman's prior history of receiving Tdap. A retrospective cohort study to assess the safety of Tdap vaccination in pregnant women in two Vaccine Safety Datalink (VSD) sites during 2010-2012 found a small but statistically significant increased risk of chorioamnionitis. Objective: We conducted a review of the VAERS database to describe reports of chorioamnionitis following receipt of any vaccines. Methods: We searched the VAERS database for reports of chorioamnionitis after any vaccine during the period from July 1, 1990 through February 2, 2014. Results: VAERS received 31 reports of chorioamnionitis out of 3389 pregnancy reports in 24 years. The three most common vaccines in these reports were H1N1, quadrivalent human papillomavirus (HPV4), and Tdap vaccines in 32%, 29% and 26% of reports, respectively. Fifty-eight percent of reports had at least one reported risk factor for chorioamnionitis. Chorioamnionitis was identified in 3 reports of spontaneous abortions and 6 stillbirths, 6 reports of preterm birth (two of whom died) and 16 reports of term birth; maternal outcomes included two reports of postpartum hemorrhage and one report of maternal admission to the intensive care unit. No maternal deaths were reported. Conclusion: Chorioamnionitis was found to be uncommonly reported, representing 1% of pregnancy reports to VAERS. A majority of reports had at least one risk factor for chorioamnionitis. Two female patient, whose medical history and concomitant medications were not reported, had received a dose of IIV3 or Trivalent Inactivated Influenza Vaccine (batch number, route and site of administration were not reported) on unspecified date. On unspecified date, following vaccination, two patients experienced chorioamnionitis and was pregnant during vaccination. The last menstrual period and estimated date of delivery was not reported. Gestation period at exposure was unknown. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: chorioamnionitis and vaccine exposure during pregnancy. Documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Amniotic cavity infection, Exposure during pregnancy
Clinical narrative: Initial unsolicited report received from literature on 18 June 2015. This case is linked to 2015SA090249, 2015SA090257, 2015SA090259, 2015SA090260, 2015SA090261 and 2015SA090262. (Same literature, reporter and event). Abstract: Background: In October 2012, the Committee recommended dose of Tdap during each pregnancy, irrespective of the woman's prior history of receiving Tdap. A retrospective cohort study to assess the safety of Tdap vaccination in pregnant women in two Vaccine Safety Datalink (VSD) sites during 2010-2012 found a small but statistically significant increased risk of chorioamnionitis. Objective: We conducted a review of the VAERS database to describe reports of chorioamnionitis following receipt of any vaccines. Methods: We searched the VAERS database for reports of chorioamnionitis after any vaccine during the period from July 1, 1990 through February 2, 2014. Results: VAERS received 31 reports of chorioamnionitis out of 3389 pregnancy reports in 24 years. The three most common vaccines in these reports were H1N1, quadrivalent human papillomavirus (HPV4), and Tdap vaccines in 32%, 29% and 26% of reports, respectively. Fifty-eight percent of reports had at least one reported risk factor for chorioamnionitis. Chorioamnionitis was identified in 3 reports of spontaneous abortions and 6 stillbirths, 6 reports of preterm birth (two of whom died) and 16 reports of term birth; maternal outcomes included two reports of postpartum hemorrhage and one report of maternal admission to the intensive care unit. No maternal deaths were reported. Conclusion: Chorioamnionitis was found to be uncommonly reported, representing 1% of pregnancy reports to VAERS. A majority of reports had at least one risk factor for chorioamnionitis. Three female patient, whose medical history and concomitant medications were not reported, had received a dose of IIV3 or Trivalent Inactivated Influenza Vaccine (batch number, route and site of administration were not reported) and also received a dose of H1N1 (batch number, route and site of administration were not reported) on unspecified date. On unspecified date, after vaccination, three patients experienced chorioamnionitis and was pregnant during vaccination. The last menstrual period and estimated date of delivery was not reported. Gestation period at exposure was unknown. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: chorioamnionitis and vaccine exposure during pregnancy. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Amniotic cavity infection, Exposure during pregnancy
Clinical narrative: Initial unsolicited report received from literature on 18 June 2015. This case is linked to case ID's: 2015SA090249, 2015SA090258, 2015SA090259, 2015SA090260, 2015SA090261, 2015SA090262. (Same literature, reporter and event) Abstract: Background: In October 2012, the committee recommended dose of Tdap during each pregnancy, irrespective of the woman's prior history of receiving Tdap. A retrospective cohort study to assess the safety of Tdap vaccination in pregnant women in two Vaccine Safety Datalink (VSD) sites during 2010-2012 found a small but statistically significant increased risk of chorioamnionitis. Objective: We conducted a review of the VAERS database to describe reports of chorioamnionitis following receipt of any vaccines. Methods: We searched the VAERS database for reports of chorioamnionitis after any vaccine during the period from July 1, 1990 through February 2, 2014. Results: VAERS received 31 reports of chorioamnionitis out of 3389 pregnancy reports in 24 years. The three most common vaccines in these reports were H1N1, quadrivalent human papillomavirus (HPV4), and Tdap vaccines in 32 percent, 29 percent and 26 percent of reports, respectively. Fifty-eight percent of reports had at least one reported risk factor for chorioamnionitis. Chorioamnionitis was identified in 3 reports of spontaneous abortions and 6 stillbirths, 6 reports of preterm birth (two of whom died) and 16 reports of term birth; maternal outcomes included two reports of postpartum hemorrhage and one report of maternal admission to the intensive care unit. No maternal deaths were reported. Conclusion: Chorioamnionitis was found to be uncommonly reported, representing 1 percent of pregnancy reports to VAERS. A majority of reports had at least one risk factor for chorioamnionitis. Five female patients, whose medical history and concomitant medications were not reported, had received a dose of TDAP (batch number, route and site of administration were not reported) on an unspecified date. On unspecified date, after vaccinations, patients experienced chorioamnionitis and were pregnant during vaccination. The last menstrual period and estimated date of delivery was not reported. Gestation period at exposure was unknown. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: chorioamnionitis and vaccine exposure during pregnancy. Documents held by sender: none.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Amniotic cavity infection, Exposure during pregnancy
Clinical narrative: Initial unsolicited literature report received from a healthcare professional on 18 June 2015. This case is linked to case ID's: 2015SA090257, 2015SA090258, 2015SA090259, 2015SA090260, 2015SA090261, 2015SA090262. (Same literature, reporter and event). Abstract: Background: In October 2012, the committee recommended dose of Tdap during each pregnancy, irrespective of the woman's prior history of receiving Tdap. A retrospective cohort study to assess the safety of Tdap vaccination in pregnant women in two Vaccine Safety Datalink (VSD) sites during 2010-2012 found a small but statistically significant increased risk of chorioamnionitis. Objective: We conducted a review of the VAERS database to describe reports of chorioamnionitis following receipt of any vaccines. Methods: We searched the VAERS database for reports of chorioamnionitis after any vaccine during the period from July 1, 1990 through February 2, 2014. Results: VAERS received 31 reports of chorioamnionitis out of 3389 pregnancy reports in 24 years. The three most common vaccines in these reports were H1N1, quadrivalent human papillomavirus (HPV4), and Tdap vaccines in 32 percent, 29 percent and 26 percent of reports, respectively. Fifty-eight percent of reports had at least one reported risk factor for chorioamnionitis. Chorioamnionitis was identified in 3 reports of spontaneous abortions and 6 stillbirths, 6 reports of preterm birth (two of whom died) and 16 reports of term birth; maternal outcomes included two reports of postpartum hemorrhage and one report of maternal admission to the intensive care unit. No maternal deaths were reported. Conclusion: Chorioamnionitis was found to be uncommonly reported, representing 1 percent of pregnancy reports to VAERS. A majority of reports had at least one risk factor for chorioamnionitis. Seven female patients, whose medical history and concomitant medications were not reported, had received a dose of H1N1 (batch number, route and site of administration were not reported) on an unspecified date. On unspecified date after vaccinations, patients experienced chorioamnionitis and patients were pregnant during vaccination. The last menstrual period and estimated date of delivery was not reported. Pregnancy exposure timing was unknown. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: chorioamnionitis and vaccine exposure during pregnancy. Documents held by sender: none.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administration error, Underdose
Clinical narrative: HAD DIFFICULTY INJECTING THE ZOSTAVAX VACCINE INTO HER LEFT ARM....HAD TO REMOVE NEEDLE, REPLACE WITH DIFFERENT NEEDLE, AND POKE AGAIN...THIS HAPPENED 3 MORE TIMES IN LEFT ARM...ON FIFTH TRY, INJECTED INTO HER RIGHT ARM, SAME PROBLEM..0.04ML OF VACCINE REMAINED.
Sex: F
Vaccine: HEP, TD, VARCEL
Symptoms: Amniotic cavity infection, Exposure during pregnancy
Clinical narrative: Initial unsolicited literature report received from healthcare professional on 18 June 2015. This case is linked to case ID's: 2015SA090249, 2015SA090258, 2015SA090259, 2015SA090260, 2015SA090261, 2015SA090257. (Same literature, reporter and event). Abstract: Background: In October 2012, the Committee recommended dose of Tdap during each pregnancy, irrespective of the woman's prior history of receiving Tdap. A retrospective cohort study to assess the safety of Tdap vaccination in pregnant women in two Vaccine Safety Datalink (VSD) sites during 2010-2012 found a small but statistically significant increased risk of chorioamnionitis. Objective: We conducted a review of the VAERS database to describe reports of chorioamnionitis following receipt of any vaccines. Methods: We searched the VAERS database for reports of chorioamnionitis after any vaccine during the period from July 1, 1990 through February 2, 2014. Results: VAERS received 31 reports of chorioamnionitis out of 3389 pregnancy reports in 24 years. The three most common vaccines in these reports were H1N1, quadrivalent human papillomavirus (HPV4), and Tdap vaccines in 32%, 29% and 26% of reports, respectively. Fifty-eight percent of reports had at least one reported risk factor for chorioamnionitis. Chorioamnionitis was identified in 3 reports of spontaneous abortions and 6 stillbirths, 6 reports of preterm birth (two of whom died) and 16 reports of term birth; maternal outcomes included two reports of postpartum hemorrhage and one report of maternal admission to the intensive care unit. No maternal deaths were reported. Conclusion: Chorioamnionitis was found to be uncommonly reported, representing 1% of pregnancy reports to VAERS. A majority of reports had at least one risk factor for chorioamnionitis. A female patient, whose medical history and concomitant medications were not reported, had received a dose of Hepatitis B vaccine, a dose of Varicella vaccine and a dose of TD (batch number, route and site of administration were not reported for all vaccines) on unspecified date. On unspecified date after vaccinations, the patient experienced chorioamnionitis and was pregnant during vaccination. The last menstrual period and estimated date of delivery were not reported. Gestation period at exposure was unknown. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: chorioamnionitis and vaccine exposure during pregnancy. Documents held by sender: none.
Sex: F
Vaccine: HPVX, TDAP
Symptoms: Amniotic cavity infection, Exposure during pregnancy
Clinical narrative: Initial unsolicited literature report received from a healthcare professional on 18 June 2015. This case is linked to case ID's: 2015SA090249, 2015SA090258, 2015SA090259, 2015SA090257, 2015SA090260, 2015SA090262. (Same literature, reporter and event). Abstract: Background: In October 2012, the committee recommended dose of Tdap during each pregnancy, irrespective of the woman's prior history of receiving Tdap. A retrospective cohort study to assess the safety of Tdap vaccination in pregnant women in two Vaccine Safety Datalink (VSD) sites during 2010-2012 found a small but statistically significant increased risk of chorioamnionitis. Objective: We conducted a review of the VAERS database to describe reports of chorioamnionitis following receipt of any vaccines. Methods: We searched the VAERS database for reports of chorioamnionitis after any vaccine during the period from July 1, 1990 through February 2, 2014. Results: VAERS received 31 reports of chorioamnionitis out of 3389 pregnancy reports in 24 years. The three most common vaccines in these reports were H1N1, quadrivalent human papillomavirus (HPV4), and Tdap vaccines in 32 percent, 29 percent and 26 percent of reports, respectively. Fifty-eight percent of reports had at least one reported risk factor for chorioamnionitis. Chorioamnionitis was identified in 3 reports of spontaneous abortions and 6 stillbirths, 6 reports of preterm birth (two of whom died) and 16 reports of term birth; maternal outcomes included two reports of postpartum hemorrhage and one report of maternal admission to the intensive care unit. No maternal deaths were reported. Conclusion: Chorioamnionitis was found to be uncommonly reported, representing 1 percent of pregnancy reports to VAERS. A majority of reports had at least one risk factor for chorioamnionitis. A female patient, whose medical history and concomitant medications were not reported, had received a dose of TDAP and a dose of HPV4 (batch number, route and site of administration were not reported for all vaccines) on unspecified date. On unspecified date after vaccinations, patient experienced chorioamnionitis and it was reported that patient was pregnant during vaccination. The last menstrual period and estimated date of delivery were not reported. Pregnancy exposure timing was unknown. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: chorioamnionitis and vaccine exposure during pregnancy. Documents held by sender: none.
Age: 44.0
Sex: M
Vaccine: RAB
Symptoms: Conjunctivitis, Erythema multiforme, Stevens-Johnson syndrome, Vasculitis
Clinical narrative: Initial unsolicited report received from a health authority on 05 June 2015. A 44-year-old male patient, whose medical history and concomitant medications were not reported, had received a second dose of IMOVAX (batch number, expiry date, dose, dose number, route and site of administration were not reported) on an unspecified date. It was reported that, on an unspecified date patient had previously received first dose of IMOVAX, however according to immunization recommendations it should be one week previously. On an unspecified date, one day after vaccination patient had experienced "Stevens Johnson, erythema multiforme, vasculitis and conjunctivitis". Laboratory investigations and corrective treatments were not reported. At the time of this report, patient had recovered. The health authority assessed the causal association between rabies vaccine and EM/SJS (erythema multiforme/Stevens Johnson Syndrome) as possible. Documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: Sensory loss
Clinical narrative: This spontaneous report as received from a healthcare worker, via field employee, refers to a 10 year old male patient. The patient's current conditions and medical history were not reported. On approximately 03-JUN-2015 (reported as 2.5 weeks ago), the patient was vaccinated with GARDASIL. Concomitant medications were not reported. Four days later, on approximately 07-JUN-2015, the patient found that he "had no feeling below his navel". The outcome of the event was unknown. The patient's physician stated that the event was vaccine related, and hence related to GARDASIL use. There was no product quality complaint involved. Upon internal review, the event was considered serious due to possible disability. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 07-MAY-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 13-APR-2015 the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 09-FEB-2015 the patient was received improperly stored VARIVAX (Merck) lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to medication.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been receive from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients received improperly stored ROTATEQ (lot# K001935, expiration date: 08-DEC-2015, lot# reported as K023537, expiration date: 22-JUN-2016, oral, dose was unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt had extreme swelling around the injection site w/an extrmely red bulls-eye that is hot to the touch.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Stated to become more noticeable on day 3 of vaccine then today 4 red area larger than baseball size and warm to touch and now going around arm. Treatment, cold compress and BENADRYL.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unspecified date in 2014 (a year ago), the patient received her first dose of GARDASIL (lot #, expiration date, dose and route were not reported) and on 24-JUN-2015, she received a second dose of GARDASIL (lot#, expiration date, dose and route were not reported). No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEPA, IPV
Symptoms: Injection site rash, Injection site urticaria, Rash, Urticaria
Clinical narrative: At 2230 on 6/25/15 pt had hives/rash on bilateral arms, feet and legs. Parent administering BENADRYL 5mL q4-6h around the clock. Medication helping the symptoms.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Leukocytosis, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from the authors in a literature article concerning a 3 year old female patient who was vaccinated with PCV (23-valent) (manufacturer unknown) and had received 13-valent PCV 1 year earlier. No concomitant vaccines were reported. The 3 year old girl with sickle cell disease type hemoglobin SS SCD was brought to the emergency department with pain and swelling of the right leg 1 day after administration of PPSV23 (manufacturer unknown). She was febrile (39.3 degrees C), with a WBC (white blood cell) count of 17.2 x 1000/mm3 that showed leucocytosis on admission (also reported as 17.2 x 1000/mm3 before immunization). The patient was hospitalized for 2 days and received empiric ceftriaxone. She was afebrile during her entire admission, and her swelling markedly decreased after 1 day so that she was without pain on discharge. This is one of several reports from the same literature (1506USA013115, 1506USA013114, 1506USA013112 and 1506USA013113). Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Swelling down left arm to elbow. Area was red & itchy w/rash 10 days after injection.
Age: 21.0
Sex: M
Vaccine: HEPAB, IPV, TD
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Person reports since last Monday can't raise arm (left) above shoulder b/c of pain. Reports he went to school nurse for ice, can shrug shoulders, can move arm below elbow. Pain is 7/10, has not taken anything for pain, can move one finger& wrists, bilat, is able to perform ADLs/dress self. Drd not call PCP.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 30-JAN-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798, expiration date 12-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 12-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798, expiration date 12-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Age: 9.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal discomfort, Pyrexia, Somnolence
Clinical narrative: Mom reports; Fever, GI upset and was a little sleepy, the evening of vaccine administration.
Age: 1.28
Sex: F
Vaccine: DTAP
Symptoms: Allergy to metals, Biopsy, Injection site nodule
Clinical narrative: Subcutaneous nodule at site of immunization- DTap.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 17-MAR-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medications was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 18-MAR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 04-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistnat (C.M.A.) concerning a patient of unknown age and gender. The patient's emdical history, concurrent condition and concomitant hterapy were not reported. On 18-MAR-2015, the patient was vaccinated wiht a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional informaiton is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 12-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 19-FEB-2015, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD, lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On 29-MAY-2015, the patient was inadvertently vaccinated with 0.5 ml dose of PROQUAD (Merck) subcutaneously (lot # and expiration date were not reported) that had been improperly stored. No adverse effects were reported. Additional information is not expected, as the reporter did not wish any further contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 24-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: The patient stated that the day of his PREVNAR 13 vaccination on 6/5/15 he started to note some pain in his right deltoid. He denies any redness, warmth or swelling. He states that he has constant pain in the deltoid with some radiation into his forearm which has since subsided. When I get up in the night it hurts a lot, it hurts to just let it hang. This is new and different for him. No other changes in activity just prior to his shot. He finds that taking Tramadol will help with the pain but he doesn't like to take it too often. The pain is worst at night when he is sleeping and in the morning when he first wakes up.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (lot #, expiration date, dose and route were not reported). On an unknown date, the patient was vaccinated with RECOMBIVAX HB (lot #, expiration date, dose and route were not reported). On an unknown date, the patient had negative titers after receiving RECOMBIVAX HB. The outcome of negative titers was unknown. The relatedness between adverse event and RECOMBIVAX HB was not reported. Additional information is not expected due to contact Health Care Professional was given.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 18-JUN-2015 the patient was inadvertently vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # L001326; expiration date: 13-JAN-2017) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site discolouration, Injection site erythema
Clinical narrative: Had vaccine PREVNAR 6/15 (R) arm -> later that day developed black and blue around site and then redness then next morning around the black and blue. Went to ER. Diagnosis of cellulitis. Treatment of antibiotics with clindamycin.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 12-JUN-2015 the patient was inadvertently vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # L001326; expiration date: 13-JAN-2017) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Rash
Clinical narrative: This spontaneous report was received from a male patient of unknown age. The concurrent condition of the patient included neuropathy, allergy to LIPITOR and CELEBREX. On an unknown date in March 2015, also reported as about 2 months ago, the patient was vaccinated with ZOSTAVAX (dose and route of administration was not reported) for prevention of shingles. Concomitant therapies included NEURONTIN, adefovir dipivoxil and vitamin B complex. The patient reported that his neuropathy was getting better until he received ZOSTAVAX. Before vaccination it was only in his legs but after vaccination, the patient felt throbbing from his toes to his shoulders. On 26-MAY-2015, the patient was lounging in the sun. On 27-MAY-2015, the throbbing was really bothering him. On an unknown date in 2015, the patient experienced redness and a rash on his groin area. The patient sought medical attention and called physician. The physician recommended to see neurologist. The vaccine was not reintroduced. The outcome of the events was reported as not recovered. No product quality issue was involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a 26 year old female consumer referring to herself. Pertinent medical history and concurrent conditions were not reported. At the time of this report, the patient had none drug reactions or allergies. On 24-MAR-2015 the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, anatomical location, lot number and expiration date were unspecified). On an unknown date in May 2015 the patient was vaccinated with the second dose of GARDASIL (strength, dose, route, anatomical location, lot number and expiration date were unspecified). None concomitant therapies were reported.  On an unknown date, after receiving the second dose, the patient became pregnant with LMP of May 2015 (unspecified day). The pregnancy outcome  was pending so the fetal outcome was unknown. The patient did not seek medical attention, there were no laboratory diagnostics performed, and no treatment was given for the adverse event. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 09-JUN-2015 the patient was inadvertently vaccinated with a dose of improperly stored PROQUAD (Merck) (Lot# K018143; expiration date: 10-APR-2016) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 10-JUN-2015 the patient was inadvertently vaccinated with a dose of improperly stored PROQUAD (Merck) (Lot# K018143; expiration date: 10-APR-2016) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 11-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 30-JAN-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects  were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.