chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US014840 is an initial spontaneous report received from a nurse on 10 Jul 2013. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The patient was vaccinated only with the MenCYW-135 liquid conjugate component of MENVEO (batch number: X12023) intramuscularly and did not receive MenA lyophilized conjugate on 10 Jul 2013. The nurse stated that she thought that it was saline at first. Once she realized the error, she reconstituted a dose of MENVEO and re-vaccinated with patient with the full dose. No adverse reaction was reported following the inadvertent administration.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US014814 is an initial spontaneous report received from a nurse on 10 Jul 2013. This report refers to a 20-year-old female patient. Her medical history and concomitant medication were not reported. She received only Men CYW-135 liquid component of MENVEO (batch number: A11082) intramuscularly on 05 Jul 2013, without being reconstituted with Men A. No adverse event was reported following medication error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US015036 is an initial spontaneous report received from a medical assistant on 12 Jul 2013, and with a follow up report received on 06 Aug 2013: This report refers to a 12 year old male child. His medical history was not reported. Concomitant medication included FORMITEX. He was given only the Men A component of MENVEO (batch number: X12118) intramuscularly on 11 Jul 2013. MenA was reconstituted with water instead of MenCYW-135. He was instructed to revaccinate with both the components. No adverse event was reported following this administration error. Follow up report received on 06 Aug 2013. Updated concomitant drug.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US015020 is an initial spontaneous report from the health care professional (practice administrator) received on 12 Jul 2013. This report refers to a 15-year-old female patient. On 16 May 2013, the patient was accidentally vaccinated with only MenCYW-135 liquid component of MENVEO (batch number: X11075) and did not receive Men A lyophilized conjugate. No adverse event reported following this mal-administration. No other information was available.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US015037 is an initial spontaneous report received from a nurse on 12 Jul 2013, and with a follow up report received on 06 Aug 2013. This report refers to an 18-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with an intramuscular dose of MenCYW-135 liquid  conjugate component of MENVEO (batch number: M12094) without being reconstituted with MenA lyophilized conjugate on 12 Jul 2013. No adverse events were reported following the maladministration. Follow up report received on 06 Aug 2013. Updated batch number.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US015047 is an initial spontaneous report received from a nurse on 12 Jul 2013. This report refers to an 11 year old patient (gender not reported). Medical history and concomitant medications were not reported. The patient received an intramuscular dose of 0.5 ml MENVEO (batch number: 12013) on 01 Apr 2013. It was reported that the patient possibly received Men A lyophilized conjugate of MENVEO diluted with sterile water instead of being reconstituted with MenCYW-135 liquid conjugate. It was reported that a box of MENVEO was found with one full dose and one vial of powder, but without diluent. The patient would be re-vaccinated. No adverse event was reported following maladministration.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US015050 is an initial spontaneous report received from a nurse on 12 Jul 2013. This report refers to an 11 year old patient (gender not reported). Medical history and concomitant medications were not reporter. The patient received an intramuscular dose of 0.5 ml MENVEO (batch number: 12013) on 25 Mar 2013. It was reported that the patient possibly received MenA lyophilized conjugate of MENVEO diluted with sterile water instead of being reconstituted with MenCYW-135 liquid conjugate. It was reported that a box of MENVEO was found with one full dose and one vial of powder, but without diluent. The patient would be re-vaccinated. No adverse event was reported following maladministration.
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US015052 is an initial spontaneous report received from a nurse on 12 Jul 2013. This report refers to an adult patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The patient's vaccination history included administration of MENACTRA (other manufacturer, batch number: not reported) on 29 Aug 2008. The patient received an intramuscular dose of 0.5 ml MENVEO (batch number: 12013) on 13 Mar 2013. It was reported that the patient possibly received MenA lyophilized conjugate of MENVEO diluted with sterile water instead of being reconstituted with MenCYW-135 liquid conjugate. It was reported that a box of MENVEO was found with one full dose and one vial of powder, but without diluent. The patient would be re-vaccinated. No adverse event was reported following maladministration.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number of PHEH2013US015144 is an initial spontaneous report received from a health care professional on 16 Jul 2013: This report refers to a patient of unknown age and gender. This patient was only given MenCYW-135 component of MENVEO (batch number: M11073), without being reconstituted with MenA, on an unspecified date. No adverse event was reported following this administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US014762 is an initial spontaneous report received from a medical assistant on 09 Jul 2013. This report refers to an 11-years-old male patient. His medical history and concomitant medications were not reported. It was reported that on 09 Jul 2013 he was vaccinated only with MenCYW-135 liquid conjugate of MENVEO (batch number: X12025) intramuscularly and did not receive the MenA lyophilized conjugate. No adverse event was reported following the maladministration.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US014700 is an initial spontaneous report from the health care professional (practice manager) received on 08 Jul 2013. This report refers to a 12-year-old female patient. On 05 Jul 2013, the patient was vaccinated with Men A lyophilized conjugate of MENVEO (batch number: A12120) mixed with a sterile diluent, instead of MenCYW-135 liquid component. No adverse event reported following the mal-administration. No other information was available. Following an internal review on 16 Jul 2013 a non-significant correction done for the information received on 08 Jul 2013: The LLT of the event inappropriate preparation of medication, changed to wrong solution used in the drug reconstitution as per non serious line listings.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product container issue
Clinical narrative: Case number PHEH2013US014641 is an initial spontaneous report received from a health care professional on 01 Jul 2013 with a follow up information received from a nurse on 16 Jul 2013. This is also a PTC complaint (reference number: 238305). This report refers to a patient of an unknown age and gender. Patient was vaccinated with MENVEO (batch number: M12025, expiry date: 31 Dec 2014) at a dose of 0.5 ml, on an unspecified date. It was reported that nurse had a trouble withdrawing MENVEO vaccine after it was reconstituted. A full dose was withdrawn but had to remove both the mental with a sterile adson forceps, before administering the dose. It was stated that MENVEO vial was malfunctioned and hence the metal cap was removed to withdraw the vaccine, but there was still a rubber stopper left, so there was no contamination. The full dose was administered to the patient. The reporter did not remember the patient and hence could not provide patient's information. No adverse event was reported following medication errors. Follow up information received from a nurse on 16 Jul 2013: Events updated (product contained issue was added and exposure to contaminated air was deleted).
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US014623, is an initial spontaneous report received from a pharmacist on 03 Jul 2013: This case refers to a male patient of unspecified age. He was vaccinated with expired MENVEO (batch number: A10051 and expiry date: Jan 2013), intramuscularly on 03 Jul 2013. No adverse reaction was reported following this administration error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US014619, is an initial spontaneous report received from a healthcare professional on 03 Jul 2013: This case refers to an 18-year-old female patient. Previously, she was vaccinated with meningococcal vaccine (manufacture and batch number: unknown) in 2009. She received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: X11082 and expiry date: Jun 2014), intramuscularly without being reconstituted with Men A component on 12 Jun 2013. However reporter does not known which of the two patients received only a partial dose of MENVEO. No adverse reaction reported following this administration error.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US014618, is an initial spontaneous report received from a nurse on 03 Jul 2013 with a follow-up received on 24 Jul 2013: This case refers to a 14-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: A12095), intramuscularly in to the right deltoid without being reconstituted with Men A component on 03 Jul 2013. No adverse reaction was reported following this administration error. Follow-up received from the nurses on 24 Jul 2013: Updated patient demographics and site of administration of MENVEO.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US014617, is an initial spontaneous report received from a healthcare professional on 03 Jul 2013: this case refers to a 14-year-old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine ( batch number: X11082 and expiry date: Jun 2014), intramuscularly without being reconstituted with Men A Component on 13 May 2013. This was the first dose of MENVEO vaccine. However reporter does not know which of the two patients received only a partial dose of MENVEO. No adverse reaction reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US014363, is an initial spontaneous report received from a nurse on 02 Jul 2013, and with a follow up report received from nurse on 05 Aug 2013. This case refers to  11 year old female patient. Her medical history included Osgood-Schlatter's disease. Concomitant medication included Albuterol for use when needed. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: M12025), intramuscularly without being reconstituted with men A Component on 28 Jun 2013. On the same date he concomitantly received ADACEL (batch number: unknown). No adverse reaction was reported following this administration error. Follow up report received from nurse on 05 Aug 2013. Updated patient demographics, medical history, concomitant drugs and vaccination date.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US014352, is an initial spontaneous report received from a pharmacist on 02 Jul 2013. This report refers to a 16-year-old male patient. He received only Men A lyophilized conjugate component of MENVEO, (batch number: A12093) reconstituted with sterile water intramuscularly on 02 Jul 2013 at 14:25 PM. He did not receive the MENVEO vaccine. No adverse reaction was reported following this administration error.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US014351, is an initial spontaneous report received from a nurse on 02 Jul 2013. This case refers to a 12-year-old female patient. She inadvertently received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: X11064), intramuscularly without being reconstituted with Men A component on 20 Jun 2013. No adverse reaction reported following this administration error.
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US014337, is an initial spontaneous report received from a physician on 02 Jul 2013. this report refers to an 18-year-old female patient. her medical history and concomitant medication were not reported. She received only Men A lyophilized conjugate component of MENVEO vaccine (batch number: A 12006) reconstituted with sterile water intramuscularly on 01 Jul 2013. No adverse reaction was reported following this administration error.
Age: 0.92
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US014233 is an initial spontaneous report from the nurse received on 28 Jun 2013. This report refers to a 10-month-old male patient was vaccinated with MENVEO (batch number: not reported) on 11 Sep 2012 via intramuscular route. No adverse reactions occurred following this medication error. No other information was available.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US014196, is an initial spontaneous report received from a nurse on 27 Jun 2013. This case refers to an 11-year-old male patient. His medical history and concomitant medication were not provided. He was vaccinated with MENVEO, batch number: M12118 and expiry date: Aug 2014), at a dose of 0.5 ml intramuscularly on 20 Jun 2013. Reporter stated that, MENVEO vaccine was stored at 4.6 F for 4 hours on 20 Jun 2013 and does not know if vaccine was frozen. No adverse event was reported following this administration error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US014194, is an initial spontaneous report received from a nurse on 27 Jun 2013. This case refers to a 16-year-old female patient. Her medical history and concomitant medication were not provided. She was vaccinated with MENVEO, (batch number: M12118 and expiry date: Aug 2014), at a dose of 0.5 ml intramuscularly on 19 Jun 2013. Reporter stated that, MENVEO vaccine was stored at 11F on 19 Jun 2013 and does not know if vaccine was frozen. No adverse event was reported following this administration error.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US013965, is an initial spontaneous report received from the pharmacist on 26 Jun 2013, and with a follow up report received from pharmacist on 30 Jul 2013. This report refers to an 18-year-old male patient. His medical history and concomitant medication were not reported. He received only MENVEO, (batch number: X11082), intramuscularly without being reconstituted with Men A component on 26 Jun 2013. On the same day he received BOOSTRIX, (batch number: 739Y2) at a dose of 0.5 ml intramuscular. He was revaccinated with the correct dose of MENVEO, (batch number: X11082/A11082) that included liquid and lyophilized conjugate to complete vaccine on 27 Jun 2013. No adverse reaction was reported following this administration error. Follow up report received from pharmacist on 30 Jul 2013. Updated concomitant vaccine and revaccination.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US013854 is an initial spontaneous report received from a nurse on 24 Jun 2013. This case refers to a 12-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated intramuscularly with MenCYW liquid conjugate component of MENVEO (batch number: M120193), instead of being reconstituted with MenA component on 24 Jun 2013. No adverse event was reported following this drug administration error. No other information was available at the time of this report.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US013759 is an initial spontaneous report received from a nurse on 25 un 2013. This case refers to a 17-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated only with MenCYW-135 component of MENVEO (batch number: A12025) intramuscularly on 24 Jun 2013. No adverse event was reported at the time of this report. No other information was available.
Age: 1.0
Sex: U
Vaccine: MMR, MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US0113520 is an initial spontaneous report received from a nurse on 21 Jun 2013, and with a follow up report receive on 16 Jul 2013. This report refers to a 12-month old patient of an unknown gender. The nurse reconstituted MMR vaccine powder (other manufacturer, batch number: unknown) with liquid component Men CYW-135 of MENVEO (batch number: unknown) and administered to a patient of an unspecified date. So the patient had received measles, mumps, rubella and three meningitis antigens. Nurse reported that it was unknown whether this occurred. No adverse event was reported following medication error. No further information was provided. Follow up report received from nurse on 16 Jul 2013. Updated narrative.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US013444 is an initial spontaneous report received from a nurse on 19 Jun 2013 with a follow-up received on 09 Jul 2013. This report refers to an 11-year-old female patient. Her past medical history and concomitant medication were not reported. She received only Men A lyophilized component of MENVEO (batch number: M12024, expired date: Dec 2014) reconstituted with a sterile diluent (not with Men CYW-135) intramuscularly on 17 Jun 2013. No adverse event was reported following medication error. The nurse reported that she would be re-vaccinated with the correctly reconstituted MENVEO. Follow-up received from the nurse on 09 Jul 2013: Updated patient demographics and information on re-vaccination.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US013416 is an initial spontaneous report received from a nurse on 19 Jun 2013, and with a follow up report received from nurse on 09 Jul 2013. This case refers to a 16-year-old male patient. His medical history was not reported. Concomitant vaccine included GARDASIL (batch number: H021194) at a dose of 0.5 ml into left deltoid on 13 Jun 2013. He was vaccinated with a booster dose of MENVEO (batch number: A1225), at a dose of 0.1 ml (under dose) intramuscularly into left deltoid on 13 Jun 2013. No adverse event was reported at the time of this report. The PTC complaint was registered with reference number 70763. No other information was available. Follow up report received from nurse on 09 Jul 2013. Updated patient demographics, concomitant vaccine, site of vaccination.
Age: 0.75
Sex: F
Vaccine: MNQ
Symptoms: Medication error, No adverse event
Clinical narrative: Case number PHEH2013US013362, is an initial spontaneous report received from a nurse on 19 Jun 2013: This case refers to a 09-month-old female patient. She was vaccinated with MENVEO, batch number: M12188 and expiry date: Aug 2014, batch number: M12023 and expiry date: Dec 2014) at dose of 0.5 ml, intramuscularly on 18 Jun 2013. No adverse reaction was reported following this administration error.
Age: 0.51
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US013359, is an initial spontaneous report received from a nurse on 19 Jun 2013: This case refers to a 06-month-old male patient. He was vaccinated with MENVEO (batch number: M120028 and expiry date: Dec 2014) at dose of 0.5 ml, intramuscularly on 18 Jun 2013. No adverse reaction was reported following this administration error.
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US013350, is an initial spontaneous report received from a physician on 18 Jun 2013: This case refers to a female patient of unspecified age. She received only Men A lyophilized conjugate component of MENVEO vaccine (batch number: A12118) reconstituted with sterile saline from the MMR vaccine (other manufacture), intramuscularly on 13 Jun 2013. She did not received Men C, Y. W-135 liquid conjugate component of MENVEO vaccine. No adverse reaction was reported following the administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US013267, is an initial spontaneous report received from a nurse on 17 Jun 2013. This report refers to an 11-year-old male patient. He received only MENVEO conjugate component  (batch number: X1224), intramuscularly without being reconstituted with MEN A component on 07 Jun 2013. No adverse reaction was reported following this administration error.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US012006, is an initial spontaneous report received from a medical assistant on 30 May 2013: This case refers to a male patient of unspecified age. He received only MENVEO, (batch number: M12026), intramuscularly without being reconstituted with Men A component on 29 May 2013. No adverse reaction reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site swelling
Clinical narrative: Case number PHEH2013US012005 is an initial spontaneous report received from an office manager on 30 May 2013. This report refers to an 11-year-old female child. She was vaccinated with MENVEO (batch number: A11082) subcutaneously on 29 May 2013 and her arm became swollen at the injection site. No further information about outcome, seriousness and causality was reported.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Abnormal behaviour, Anal pruritus, Anorectal swelling, Asthenia, Death
Clinical narrative: Received PPD (Mantoux Test) 03-01-2012 (R) forearm by RN Lot C3762AB. Tetanus, Diphtheria 03-01-2012 (R) deltoid by RN Lot C4136AA. Influenza 03-01-2012 Inactivated Vaccine (R) deltoid. Had a severe allergic reaction in 3 hrs my brain felt like it was swelling, the lady that give me a ride to the medical center, informed me, that I was responding like I am frozen. She had to physically move me to get me in my home. I began drinking lots of water, hoping I will urine those vaccine out of my body. All day on March 2nd, Friday, swelling in (R) shoulder to elbow red head lesion around the site (R) deltoid. Swelling and itching in anus area, vagina area, my back, head, bottom of feet, inner surface of the hands, mouth area, eyes itching. I went back to my doctor, on March 3rd, Saturday 2012 and a complete different staff were there MD, call other Dr at home. Dr inform me that is the way those vaccine works. Inform me that some people died from complication Dr prescribed BENADRYL. Ask me to come back to see other MD. March 1st received vaccine (sick). March 2nd sick Friday. March 3rd sick Saturday. March 4th sick Sunday. March 5th sick Monday. March 6th sick Tuesday, went to ER. March 7th (Wednesday) Doctor inform me to go back to Dr so he can see me 03/08. Dr treated me like he did not care. Inform me to continue taking my BENADRYL and come back and see him on Friday March 9th, 2012. March 9th, 2012, Friday, I got very sick lockjaw, whooping cough, weakness and the other complication from March 2nd, 2012. I see death. Someone took me to another ambulatory care center. March 9th, 2012-present.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Eye pruritus, Hypersensitivity, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Received PPD (Mantoux Test) 03-01-2012 (R) forearm by RN Lot C3762AB. Tetanus, Diphtheria 03-01-2012 (R) deltoid by RN Lot C4136AA. Influenza 03-01-2012 Inactivated Vaccine (R) deltoid. Had a severe allergic reaction in 3 hrs my brain felt like it was swelling, the lady that give me a ride to the medical center, informed me, that I was responding like I am frozen. She had to physically move me to get me in my home. I began drinking lots of water, hoping I will urine those vaccine out of my body. All day on March 2nd, Friday, swelling in (R) shoulder to elbow red head lesion around the site (R) deltoid. Swelling and itching in anus area, vagina area, my back, head, bottom of feet, inner surface of the hands, mouth area, eyes itching. I went back to my doctor, on March 3rd, Saturday 2012 and a complete different staff were there MD, call other Dr at home. Dr inform me that is the way those vaccine works. Inform me that some people died from complication Dr prescribed BENADRYL. Ask me to come back to see other MD. March 1st received vaccine (sick). March 2nd sick Friday. March 3rd sick Saturday. March 4th sick Sunday. March 5th sick Monday. March 6th sick Tuesday, went to ER. March 7th (Wednesday) Doctor inform me to go back to Dr so he can see me 03/08. Dr treated me like he did not care. Inform me to continue taking my BENADRYL and come back and see him on Friday March 9th, 2012. March 9th, 2012, Friday, I got very sick lockjaw, whooping cough, weakness and the other complication from March 2nd, 2012. I see death. Someone took me to another ambulatory care center. March 9th, 2012-present.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Malaise, Oral pruritus, Pertussis, Pruritus generalised, Skin lesion
Clinical narrative: Received PPD (Mantoux Test) 03-01-2012 (R) forearm by RN Lot C3762AB. Tetanus, Diphtheria 03-01-2012 (R) deltoid by RN Lot C4136AA. Influenza 03-01-2012 Inactivated Vaccine (R) deltoid. Had a severe allergic reaction in 3 hrs my brain felt like it was swelling, the lady that give me a ride to the medical center, informed me, that I was responding like I am frozen. She had to physically move me to get me in my home. I began drinking lots of water, hoping I will urine those vaccine out of my body. All day on March 2nd, Friday, swelling in (R) shoulder to elbow red head lesion around the site (R) deltoid. Swelling and itching in anus area, vagina area, my back, head, bottom of feet, inner surface of the hands, mouth area, eyes itching. I went back to my doctor, on March 3rd, Saturday 2012 and a complete different staff were there MD, call other Dr at home. Dr inform me that is the way those vaccine works. Inform me that some people died from complication Dr prescribed BENADRYL. Ask me to come back to see other MD. March 1st received vaccine (sick). March 2nd sick Friday. March 3rd sick Saturday. March 4th sick Sunday. March 5th sick Monday. March 6th sick Tuesday, went to ER. March 7th (Wednesday) Doctor inform me to go back to Dr so he can see me 03/08. Dr treated me like he did not care. Inform me to continue taking my BENADRYL and come back and see him on Friday March 9th, 2012. March 9th, 2012, Friday, I got very sick lockjaw, whooping cough, weakness and the other complication from March 2nd, 2012. I see death. Someone took me to another ambulatory care center. March 9th, 2012-present.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Swelling, Trismus, Vulvovaginal pruritus
Clinical narrative: Received PPD (Mantoux Test) 03-01-2012 (R) forearm by RN Lot C3762AB. Tetanus, Diphtheria 03-01-2012 (R) deltoid by RN Lot C4136AA. Influenza 03-01-2012 Inactivated Vaccine (R) deltoid. Had a severe allergic reaction in 3 hrs my brain felt like it was swelling, the lady that give me a ride to the medical center, informed me, that I was responding like I am frozen. She had to physically move me to get me in my home. I began drinking lots of water, hoping I will urine those vaccine out of my body. All day on March 2nd, Friday, swelling in (R) shoulder to elbow red head lesion around the site (R) deltoid. Swelling and itching in anus area, vagina area, my back, head, bottom of feet, inner surface of the hands, mouth area, eyes itching. I went back to my doctor, on March 3rd, Saturday 2012 and a complete different staff were there MD, call other Dr at home. Dr inform me that is the way those vaccine works. Inform me that some people died from complication Dr prescribed BENADRYL. Ask me to come back to see other MD. March 1st received vaccine (sick). March 2nd sick Friday. March 3rd sick Saturday. March 4th sick Sunday. March 5th sick Monday. March 6th sick Tuesday, went to ER. March 7th (Wednesday) Doctor inform me to go back to Dr so he can see me 03/08. Dr treated me like he did not care. Inform me to continue taking my BENADRYL and come back and see him on Friday March 9th, 2012. March 9th, 2012, Friday, I got very sick lockjaw, whooping cough, weakness and the other complication from March 2nd, 2012. I see death. Someone took me to another ambulatory care center. March 9th, 2012-present.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Case number PHHY2014US169488, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 543887) website on 29 Dec 2014 and with the follow-up information received from Quality Assurance Department (reference number: 344682) on 29 Jan 2015. This report refers to a 48 year old female patient. Her medical history and concomitant medication were none. She had no known drug allergy. She was vaccinated with FLUVIRIN (batch number: 14551P) and PNEUMOVAX (other manufacturer, batch number: K009105) both in left arm on 14 Sep 2014. On 15 Sep 2014, she experienced cellulitis and fever. Final outcome of these events was unknown. These events were reported as non-serious. Seriousness assessment of cellulitis was upgraded (medically significant) based on the NVS-IME list. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 14551P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the Quality Assurance Department (reference number: 344682) on 30 Dec 2014: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 344682) on 29 Jan 2015: Updated FLUVIRIN vaccine batch review report.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Headache, Hypersensitivity
Clinical narrative: This spontaneous report received from a patient's mother refers to her 11 year old son with no drug allergies or reactions and no pertinent medical history who on 26-JAN-2015 was vaccinated with a third dose of GARDASIL (lot # reported as K007264, expiration date 21-JAN-2016) (dose and route were not reported). There was no concomitant therapy. After receiving third dose of vaccine in the evening of 26-JAN-2015 the patient had an allergic reaction to GARDASIL with the following symptoms headache, abdominal discomfort because he felt sick in the stomach, hyperhidrosis, severe rash, peripheral swelling, cyanosis due to swelling in the hands and feet led his feet turning purple, hypoesthesia while his hands were swollen. The patient's physician said that the patient "may suffer from short or long term urticaria". The patient sought medical attention by saw doctor and was treated with BENADRYL. "Strep test" and urine test were performed (results not provided). At the time of the report, the outcome of allergy to vaccine, headache, abdominal discomfort, hyperhidrosis, rash, peripheral swelling, cyanosis, hypoesthesia and urticaria was not recovered. The reporter considered that allergy to vaccine, headache, abdominal discomfort, hyperhidrosis, rash, peripheral swelling, cyanosis, hypoesthesia and urticaria to be related to GARDASIL. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Nausea, Rash generalised, Renal function test normal, Streptococcus test negative, Swelling
Clinical narrative: This spontaneous report received from a patient's mother refers to her 11 year old son with no drug allergies or reactions and no pertinent medical history who on 26-JAN-2015 was vaccinated with a third dose of GARDASIL (lot # reported as K007264, expiration date 21-JAN-2016) (dose and route were not reported). There was no concomitant therapy. After receiving third dose of vaccine in the evening of 26-JAN-2015 the patient had an allergic reaction to GARDASIL with the following symptoms headache, abdominal discomfort because he felt sick in the stomach, hyperhidrosis, severe rash, peripheral swelling, cyanosis due to swelling in the hands and feet led his feet turning purple, hypoesthesia while his hands were swollen. The patient's physician said that the patient "may suffer from short or long term urticaria". The patient sought medical attention by saw doctor and was treated with BENADRYL. "Strep test" and urine test were performed (results not provided). At the time of the report, the outcome of allergy to vaccine, headache, abdominal discomfort, hyperhidrosis, rash, peripheral swelling, cyanosis, hypoesthesia and urticaria was not recovered. The reporter considered that allergy to vaccine, headache, abdominal discomfort, hyperhidrosis, rash, peripheral swelling, cyanosis, hypoesthesia and urticaria to be related to GARDASIL. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Abdominal discomfort, Cyanosis, Headache, Hyperhidrosis, Hypersensitivity
Clinical narrative: This spontaneous report received from a patient's mother refers to her 11 year old son with no drug allergies or reactions and no pertinent medical history who on 26-JAN-2015 was vaccinated with a third dose of GARDASIL (lot # reported as K007264, expiration date 21-JAN-2016) (dose and route were not reported). There was no concomitant therapy. After receiving third dose of vaccine in the evening of 26-JAN-2015 the patient had an allergic reaction to GARDASIL with the following symptoms headache, abdominal discomfort because he felt sick in the stomach, hyperhidrosis, severe rash, peripheral swelling, cyanosis due to swelling in the hands and feet led his feet turning purple, hypoesthesia while his hands were swollen. The patient's physician said that the patient "may suffer from short or long term urticaria". The patient sought medical attention by saw doctor and was treated with BENADRYL. "Strep test" and urine test were performed (results not provided). At the time of the report, the outcome of allergy to vaccine, headache, abdominal discomfort, hyperhidrosis, rash, peripheral swelling, cyanosis, hypoesthesia and urticaria was not recovered. The reporter considered that allergy to vaccine, headache, abdominal discomfort, hyperhidrosis, rash, peripheral swelling, cyanosis, hypoesthesia and urticaria to be related to GARDASIL. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Hypoaesthesia, Nausea, Peripheral swelling, Rash, Streptococcus test
Clinical narrative: This spontaneous report received from a patient's mother refers to her 11 year old son with no drug allergies or reactions and no pertinent medical history who on 26-JAN-2015 was vaccinated with a third dose of GARDASIL (lot # reported as K007264, expiration date 21-JAN-2016) (dose and route were not reported). There was no concomitant therapy. After receiving third dose of vaccine in the evening of 26-JAN-2015 the patient had an allergic reaction to GARDASIL with the following symptoms headache, abdominal discomfort because he felt sick in the stomach, hyperhidrosis, severe rash, peripheral swelling, cyanosis due to swelling in the hands and feet led his feet turning purple, hypoesthesia while his hands were swollen. The patient's physician said that the patient "may suffer from short or long term urticaria". The patient sought medical attention by saw doctor and was treated with BENADRYL. "Strep test" and urine test were performed (results not provided). At the time of the report, the outcome of allergy to vaccine, headache, abdominal discomfort, hyperhidrosis, rash, peripheral swelling, cyanosis, hypoesthesia and urticaria was not recovered. The reporter considered that allergy to vaccine, headache, abdominal discomfort, hyperhidrosis, rash, peripheral swelling, cyanosis, hypoesthesia and urticaria to be related to GARDASIL. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Urine analysis, Urticaria
Clinical narrative: This spontaneous report received from a patient's mother refers to her 11 year old son with no drug allergies or reactions and no pertinent medical history who on 26-JAN-2015 was vaccinated with a third dose of GARDASIL (lot # reported as K007264, expiration date 21-JAN-2016) (dose and route were not reported). There was no concomitant therapy. After receiving third dose of vaccine in the evening of 26-JAN-2015 the patient had an allergic reaction to GARDASIL with the following symptoms headache, abdominal discomfort because he felt sick in the stomach, hyperhidrosis, severe rash, peripheral swelling, cyanosis due to swelling in the hands and feet led his feet turning purple, hypoesthesia while his hands were swollen. The patient's physician said that the patient "may suffer from short or long term urticaria". The patient sought medical attention by saw doctor and was treated with BENADRYL. "Strep test" and urine test were performed (results not provided). At the time of the report, the outcome of allergy to vaccine, headache, abdominal discomfort, hyperhidrosis, rash, peripheral swelling, cyanosis, hypoesthesia and urticaria was not recovered. The reporter considered that allergy to vaccine, headache, abdominal discomfort, hyperhidrosis, rash, peripheral swelling, cyanosis, hypoesthesia and urticaria to be related to GARDASIL. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HIBV, IPV, PPV
Symptoms: Injection site discolouration, Injection site urticaria, Pruritus, Swelling face, Urticaria
Clinical narrative: She broke out in hives all over her body and made her face slightly puffy. The hives made her a little itchy. It became purple under some of the hives around the injection site. We were told to give her Benadryl.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: On 2/4/15, 31 yo M was seen in clinic for office visit. During this visit, pt was ordered to receive pneumococcal polysaccharide vaccine 23-valent (PNEUMOVAX-23). At 0841, LPN injected 0.5 mL of lot #K012424 (Merck; exp: 6/5/16) subcutaneously into pt's right arm. During this same visit, the pt received an influenza vaccine in left deltoid (lot # UI214AA0). On 2/6, pt called the clinic and reported that he has developed redness, swelling and a hardened area at the right arm injection site. Pt was asked to come to clinic for evaluation. On exam, the pt reported non-radiating constant aching pain in the right upper arm with a pain score of 4/10. Pt reported that the symptoms worsen with movement and palpation. Pt also endorsed a fever at home, but vitals check on presentation found a temperature WNL at 36.7 °C (98.1 °F) (Oral). Pt has self-treated with rest and ibuprofen, with no reported relief. Pt denied any chest pain, muscle weakness, numbness or tingling. MD diagnosed cellulitis and prescribed dicloxacillin (DYNAPEN) 500 MG capsule with instructions to take 1 capsule 4 times daily. Pt was also advised to take acetaminophen as needed for discomfort and follow up if symptoms do not improve or worsen.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: On 2/4/15, 31 yo M was seen in clinic for office visit. During this visit, pt was ordered to receive pneumococcal polysaccharide vaccine 23-valent (PNEUMOVAX-23). At 0841, LPN injected 0.5 mL of lot #K012424 (Merck; exp: 6/5/16) subcutaneously into pt's right arm. During this same visit, the pt received an influenza vaccine in left deltoid (lot # UI214AA0). On 2/6, pt called the clinic and reported that he has developed redness, swelling and a hardened area at the right arm injection site. Pt was asked to come to clinic for evaluation. On exam, the pt reported non-radiating constant aching pain in the right upper arm with a pain score of 4/10. Pt reported that the symptoms worsen with movement and palpation. Pt also endorsed a fever at home, but vitals check on presentation found a temperature WNL at 36.7 °C (98.1 °F) (Oral). Pt has self-treated with rest and ibuprofen, with no reported relief. Pt denied any chest pain, muscle weakness, numbness or tingling. MD diagnosed cellulitis and prescribed dicloxacillin (DYNAPEN) 500 MG capsule with instructions to take 1 capsule 4 times daily. Pt was also advised to take acetaminophen as needed for discomfort and follow up if symptoms do not improve or worsen.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: HIV test, Herpes zoster, Immunology test, Laboratory test, Scan
Clinical narrative: Shingles outbreak.
Age: 1.99
Sex: M
Vaccine: MMR
Symptoms: Cough, Eye pain, Pyrexia
Clinical narrative: Fever, and eyes were sore.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV
Symptoms: Fatigue, Lethargy, Pyrexia
Clinical narrative: Temp of 103 when picked up from daycare and through the night.  Very lethargic/tired.  Gave Tylenol every 4 hrs and still high temp 09/10/15.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: On 2/3/15, 65 yo F was seen in clinic for routine medical exam. During this visit, pt was ordered to receive pneumococcal polysaccharide vaccine 23-valent (PNEUMOVAX-23) and varicella-zoster vaccine (ZOSTAVAX). At 1035, pt was given pneumococcal vaccine 0.5 mL IM in left deltoid (Manu: Merck, lot #K012424). At 1037, pt was given varicella-zoster vaccine 0.5 mL SC in right deltoid (lot #K018176). On 2/4, pt contacted clinic and reported redness, swelling and pain about the left upper extremity. Pt was instructed to go to urgent care. On 2/5, pt was seen in urgent care clinic with worsening redness, swelling and pain and new onset fever (39.3 °C (102.7 °F) (Oral)). Pt diagnosed with cellulitis. While in clinic, pt given ceftriaxone 1 gm IM and ibuprofen 600 mg PO. Pt discharged with prescriptions for sulfamethoxazole-trimethoprim (BACTRIM DS) 800-160 mg Sig: Take 1 tablet (160 mg of trimethoprim total) by mouth 2 (two) times daily and prednisone 10 mg Sig: Take 6 tabs today, then decrease by one tab daily - 5 tabs on day 2, 4 tabs on day 3, 3 tabs on day 4, 2 tabs on day 5, 1 tab on day 6. Pt was further instructed to elevate left upper extremity, apply cool compression, use Tylenol for fever. And seek treatment for any concerning symptoms. On 2/6, pt seen in follow up with symptoms improving.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Fever approx 102-103, achey, dizzy, weak, fatigue.  Large, red and VERY tender area around injection site.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Fever approx 102-103, achey, dizzy, weak, fatigue.  Large, red and VERY tender area around injection site.
Age: 45.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Computerised tomogram abdomen abnormal, Enteritis, White blood cell count increased
Clinical narrative: I'm a ID physician who self prescribed Vivotif. With first capsule on 2/4/15 I had some abdominal pain. Lasted one day. Then with 4th pill again symptoms recurred. Went to ER. The WBC count was 14k and CT scan showed enteritis.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Awakened with headache, ear pain, red-swollen hive-like area at injection site, nausea, and burning pain at injection site.  Took Benadryl. Still "not feeling well" on 02/08/15. Took Benadryl as needed.  Reported reaction to Employee Health Nurse on 02/10/15.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Malaise, Nausea
Clinical narrative: Awakened with headache, ear pain, red-swollen hive-like area at injection site, nausea, and burning pain at injection site.  Took Benadryl. Still "not feeling well" on 02/08/15. Took Benadryl as needed.  Reported reaction to Employee Health Nurse on 02/10/15.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Eczema, Erythema, Inflammation, Milk allergy, Pruritus
Clinical narrative: By the evening legs started itching. Breakout started on lower legs. Rash changed from coin shaped to diffused. Went to dermatologist who diagnosed a type of eczema. Used topical cortisone cream but did not help so stopped using it. Instead used topical treatment with water based application of BENADRYL; it helped with itching but rash was still there. Applied SOVEREIGN SILVER for the skin rash and itching. Continued to be red and inflamed. On January 23-25, 2015 had flu and noticed that rash improved even without BENADRYL treatment by eliminating milk products while sick. Had a flare up of the legs when took ORGAIN so determined that allergy was specifically to milk protein. Food allergy started after Tdap vaccine.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: By the evening legs started itching. Breakout started on lower legs. Rash changed from coin shaped to diffused. Went to dermatologist who diagnosed a type of eczema. Used topical cortisone cream but did not help so stopped using it. Instead used topical treatment with water based application of BENADRYL; it helped with itching but rash was still there. Applied SOVEREIGN SILVER for the skin rash and itching. Continued to be red and inflamed. On January 23-25, 2015 had flu and noticed that rash improved even without BENADRYL treatment by eliminating milk products while sick. Had a flare up of the legs when took ORGAIN so determined that allergy was specifically to milk protein. Food allergy started after Tdap vaccine.