chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Joint swelling, Peripheral swelling, Swelling
Clinical narrative: Case number PHEH2012US014130 is an initial spontaneous report received from a physician on 17 Jul 2012 along with a follow-up received on 08 Aug 2012: This report refers to an 11-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M11053 and expiry date: Feb 2014) intramuscularly on to right arm along with GARDASIL (other manufacturer, batch number: 0555AE) on 12 Jul 2012. It was reported that he experienced swelling to the elbow and up through the shoulder and to the nipple on the chest on 13 Jul 2012. He was seen by physician on 16 Jul 2012 and was prescribed antibiotics (unspecified). The outcome of the event was reported as complete recovery of the patient. The causality was not assessed. No further information was available. Follow-up received from the physician on 08 Aug 2012: Updated suspect product information for GARDASIL, expiry date of MENVEO and outcome.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US013908 is an initial spontaneous report received from a medical assistant on 12 Jul 2012: This report refers to multiple patients. They were vaccinated with MENVEO (batch number: unknown) intramuscularly on unspecified dates. These vaccines had reached 34 degree Fahrenheit on 10 May 2012, 24 May 2012 and 30 May 2012. The vaccine also reached as low as 32  Fahrenheit nearly fifty times from 29 Jun 2012 to 07 Jul 2012 for approximately 30 minutes each. Vaccine was administered to three patients. No adverse event was reported following this administration error.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dyspnoea, Musculoskeletal stiffness, Pallor
Clinical narrative: Case number PHEH2012US013853 is an initial spontaneous report received from a physician on 10 Jul 2012. This case refers to a 16-year-old male patient. He was vaccinated with MENVEO vaccine (batch number: X11042/A11042) intramuscularly on 09 Jul 2012. On the same day he experienced paleness, shortness of breath and stiffness. The outcome of these events was reported as unknown. No other information was available.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US013369 is an initial spontaneous report received from a medical assistant on 02 Jul 2012. This report refers to a female patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that she was vaccinated only with MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X11075) intramuscularly on to unspecified site and did not receive MenA lyophilized conjugate on 29 Jun 2012. No adverse event was reported following the maladministration.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US013857 is an initial spontaneous report received from a nurse on 10 Jul 2012 with a follow-up received on 26 Jul 2012. This case refers to an 18-year-old female patient. She was vaccinated with MENVEO vaccine (batch number: M10135B) intramuscularly into the left arm on 28 Jun 2012. The nurse stated that this patient was administered only MenCWY liquid conjugate component, instead of being reconstituted with MenA component. No adverse event occurred following vaccination. Follow-up received from the nurse on 26 Jul 2012: Updated patient demographics.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US013850 is an initial spontaneous report received from a physician on 09 Jul 2012 with a follow up information received on 30 Jul 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that he was vaccinated only with 0.5 ml MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: M11071, expiry date: Dec 2013) intramuscularly on to unspecified site and did not receive MenA lyophilized conjugate on 09 Jul 2012. No adverse reaction was reported following the maladministration. No further information was available. Follow up information received on 30 Jul 2012: Patient demographics (weight and height) and expiry date updated.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US013368 is an initial spontaneous report received from a pharmacist on 02 Jul 2012 with a follow-up received on 01 Aug 2012: This report refers to an adult female patient. She was given only with MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X11402) intramuscularly and did not receive MenA lyophilized conjugate on 21 Jun 2012. No adverse event was reported following the maladministration. She was re-vaccinated with a full dose of MENVEO (batch number: not reported) on 01 Jul 2012. Follow-up received from the pharmacist on 01 Aug 2012: Updated patient's demographics, vaccination date and batch number of MENVEO.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case number PHEH2012US013227 is an initial spontaneous report received from a nurse on 27 Jun 2012: This report refers to a female patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: not reported) on an unspecified date in Jul 2011. It was reported that nurse vaccinated her again with MENVEO (batch number: M10062) intramuscularly on to unspecified site on 27 Jun 2012 without realizing that she had been vaccinated in Jul 2011. No adverse event was reported.
Age: 18.0
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US015686 is an initial spontaneous report received from a healthcare professional on 07 Aug 2012. This case refers to an 18-year-old patient of unspecified gender. This patient was vaccinated only with MenCWY-135 liquid component of MENVEO (batch number: M10133) without being reconstituted with MenA component of MENVEO on 01 May 2012. Thus this patient received only partial dose of MENVEO. No adverse event was reported. No other information was available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US015559 is an initial spontaneous report received from a nurse on 03 Aug 2012. This report refers to multiple patients whose identifiers were not reported. It was reported that these patients received intramuscular dose of MENVEO (batch number: M11047) that had been exposed to temperatures of minus 2.5 degree C for up to two weeks. No adverse event was reported following the maladministration. No further information was provided.
Age: 1.9
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH212US015523 is an initial spontaneous report received from a nurse on 01 Aug 2012: This report refers to a 21-months-old female infant. She was vaccinated with MENVEO (batch number: A11052/X11052) intramuscularly on 01 Aug 2012. No adverse event was reported following this medication error.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US015400 is an initial spontaneous report received from a nurse on 02 Aug 2012: This report refers to a female patient of unknown age group. She was given only the CYW-135 liquid component of MENVEO vaccine  (batch number: M11046) intramuscularly on an unknown date. No other adverse reaction was reported following this administration error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Product preparation error
Clinical narrative: Case number PHEH2012US015399 is an initial spontaneous report received from a nurse on 2 Aug 2012. This report refers to a 12-years-old male patient. He was given only the MenA powder component of MENVEO vaccine (batch number: unknown) intramuscularly, which was reconstituted with a wrong diluent that came from MMRV vaccines (manufacturer and batch number: unknown) on 30 Jul 2012. Within 24 hours after vaccination he experienced redness and swelling at injection site. The final outcome of the events was reported as not yet recovered at the time of reporting.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US015348 is an initial spontaneous report received from a health care professional on 31 Jul 2012: This report refers to multiple patients of unknown age group and gender. They were given only the C, Y, W-135 liquid component of MENVEO vaccine (batch number: A11071) intramuscularly on unknown dates. No other adverse reaction was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US015336, is an initial spontaneous report received from a nurse on 30 Jul 2012, and with a follow up received on 16 Aug 2012: This report refers to multiple patients. They were vaccinated with MENVEO (batch number: unknown) intramuscularly on undetermined dates. These vaccines were stored at 25 degree Fahrenheit temperature. The temperature excursions was occurring for almost 18 months now and this was discovered at the end in May 2012. For each occurrence the temperature was at 25 degree F for up to five minutes each time. The vaccine was not frozen. The reporter stated that their refrigerator was malfunctioning and temperature as falling below the recommended for a very short time, but that was happening frequently. The reporter did not known the patient information who received MENVEO that was stored in the refrigerator at the time when it was not working properly. No adverse event was reported following this administration error. Follow up report received from a nurse on 16 Aug 2012. The reporter stated that their refrigerator was malfunctioning and patient details were not available.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US012757 is an initial spontaneous report received from a nurse on 25 Jun 2012: This case refers to 23-years-old female patient. She was received only Men C, Y, W-125 liquid conjugate component of MENVEO vaccine (batch number:  X10131), without being reconstituted with Men A component on 25 Jun 2012. No adverse reaction occurred following this administration error.
Age: 0.4
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2012US012630 is an initial spontaneous report received from a physician on 21 Jun 2012. This case refers to a 04-month-old male baby. The baby was vaccinated with MENVEO (batch number: unknown) on 21 Jun 2012. No adverse event was reported following vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US011649 is an initial spontaneous report received from a nurse on 07 Jun 2012: This report refers to two patients of unknown age group and gender. They were given only the CYW-135 liquid component of MENVEO vaccine (Batch number: unknown) intramuscularly on 31 May 2012. No adverse reaction was reported following this administration error.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US010530 is an initial spontaneous report received from a nurse on 18 May 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that on 18 May 2012 he was vaccinated only with MenA lyophilized conjugate component of MENVEO (batch number: M11071) reconstituted with a sterile diluent; intramuscularly on to unspecified site and did not received the MenCYW-135 liquid conjugate vaccine component. No adverse reaction was reported following the maladministration.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US005712 is an initial spontaneous report received from a health care professional on 12 Mar 2012 with a follow up information received on 26 Mar 2012 and a follow up received on 23 Apr 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were not specified. His vaccination history included administration of MENACTRA (other manufacturer, batch number: unspecified) on 27 Oct 2008. It was reported that he was vaccinated only with MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X10062, expiration date: Feb 2013) intramuscularly on to left arm on 06 Feb 2012 and did not receive the MenA lyophilized conjugate vaccine component. No adverse reaction was reported following this administration error. The patient was scheduled for re-vaccination with MENVEO on an unspecified date. Follow up received on 26 Mar 2012: Updated patient demographics (height and weight), vaccination history and vaccination site. Follow up received on 23 Apr 2012: Updated patient demographics (initial), comment on re-vaccination added.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US014300 is an initial spontaneous report received from a medical assistant on 13 Jul 2012: This report refers to a patient of unknown age group and gender. This patient was given only the CYW-135 liquid component of MENVEO vaccine (batch number: unknown) intramuscularly on an undetermined date. The reporter stated that they had an extra vial which caused them to realize their mistake. No other adverse reaction was reported following this administration error.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD lot # L050910 with expiry date on 14-JUN-2017, lot # M002053 with expiry date on 11-JUL-2017 and lot # M004893 with expiry date on 26-JUL-2017. No adverse event was reported and no product quality complaint was involved. Temperature: 18.5 Fahrenheit degrees. Time Frame: 5 hours. Previous excursions: No. Was a data logger involved: Yes. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Mydriasis, Pallor, Tremor, Unresponsive to stimuli
Clinical narrative: While pt was walking out of clinic after receiving the 3 vaccines below, mother stated pt was pale, requested to sit down, and while sitting up pt began shaking uncontrollably (mother stated not violently), pupils were dilated, pt unresponsive to mother calling his name. This episode lasted about 30 seconds. Nurse was called afterwards, pt c/o stomach hurting but feeling fine, juice/granola bar given, VS WNL, pt's color returned to normal, pt aware of surroundings able to verbalize needs. UC/ER precautions given.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX lot # L040419 with expiry date on 14-OCT-2017, lot # L043622 with expiry date on 11-MAR-2017 and lot # M000761 with expiry date on 01-JAN-2018. No adverse event was reported and no product quality complaint was involved. Temperature: 18.5 Fahrenheit degrees. Time Frame: 5 hours. Previous excursions: No. Was a data logger involved: Yes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a physician via a company representative referring to a female of unknown age. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 25-MAY-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M000592, expiration date, dose and frequency unknown, intramuscular or subcutaneous Injection). On an unknown date in 2016 (reported as "after being administered PNEUMOVAX 23, the patient experienced cellulitis at injection site. The patient had sought medical attention for the event via contacting doctor's office. The patient was treated with antibiotics (brand and manufacturer unspecified) for the event. The patient had recovered from cellulitis at injection site (unspecified date in 2016). The physician had requested a lot check. The reporter did not provide the causal relationship of event and PNEUMOVAX 23. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash, Prednisone 50 mg every day.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 14-JUN-2016 the patient was vaccinated with expired dose of ROTATEQ lot # K013861/expiration date- 18-MAY-2016. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored M-M-R II (lot # L020188 and expiration date 03-JUN-2017, dose and route of administration were not reported). Concomitant therapy was not reported. The temperature of excursion was 13.3 Celsius degrees and the time frame was 11.25 hours cumulatively. It was stated that it was because of data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route, lot# and expiration date unknown) (inappropriate schedule of drug administration). And then on an unknown date, the third dose of GARDASIL 9 (dose, route, lot# and expiration date unknown) was administered only 6 and a half weeks after the second dose (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Age: 49.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician via a company representative referring to a 49 year old patient of unknown gender. On an unknown date the physician administered a dose of ZOSTAVAX (dose, route, lot # and expiration date unknown) to the patient. No adverse effects were reported. Additional information is not expected since we have no consent to contact the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates in 2016 (reported as since March 2016), patients were vaccinated with improperly stored VARIVAX (lot number, expiration date, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates in 2016 (reported as since March 2016), patients were vaccinated with improperly stored ZOSTAVAX 1 dose (lot number, expiration date and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date in 2016 (also reported as starting on or after 25-MAY-2016) unspecified number of patients were administered with improperly stored M-M-R II (lot # L012481, expiry date 10-APR-2017 and lot # L029266, expiry date 04-AUG-2017) (therapy type digital data logger) dosing details and route unknown. Concomitant medications were not reported. The administered vaccines were subjected to temperature excursion of 63.3 degree F for a time frame of 2 hours and 1 minute. It was reported that the vaccines administered were not subjected to previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored VARIVAX lot # L000453/expiration date- 06-JAN-2017, lot # L025208/expiration date- 07-JUL-2017 and lot # L025210/expiration date- 07-JUL-2017. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history and drug reactions or allergies was reported. In November 2015 (reported as "around November 9, 2015"), the patients were vaccinated with the first dose of GARDASIL 9 (dose, route of administration, anatomical location, lot # and expiry date were not specified). On an unknown dates, the patient received the third dose of GARDASIL 9 sooner then recommended six month interval. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date in 2016 (also reported as starting on or after 25-MAY-2016) unspecified number of patients were administered with improperly stored doses of ROTATEQ (lot # L033543, expiry date 30-MAY-2017) (therapy type digital data logger) dosing details and route unknown. Concomitant medications were not reported. The administered vaccines were subjected to temperature excursion of 63.3 degree F for a time frame of 2 hours and 1 minute. It was reported that the vaccines administered were not subjected to previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache in a 12-year-old female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, 4 hrs after receiving BEXSERO, the patient experienced headache, vomiting, fever and nausea. On an unknown date, the outcome of the headache, vomiting and fever were recovered/resolved and the outcome of the nausea was not recovered/not resolved. It was unknown if the reporter considered the headache, vomiting, fever and nausea to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, the patient experienced headache began vomiting and got a fever after vaccination with BEXSERO. It was reported that, the patient was no longer experiencing a headache, vomiting or fever at the time reporting, but was just a little nauseous. No further information was provided.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Body temperature increased, Headache, Nausea, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache in a 12-year-old female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, 4 hrs after receiving BEXSERO, the patient experienced headache, vomiting, fever and nausea. On an unknown date, the outcome of the headache, vomiting and fever were recovered/resolved and the outcome of the nausea was not recovered/not resolved. It was unknown if the reporter considered the headache, vomiting, fever and nausea to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, the patient experienced headache began vomiting and got a fever after vaccination with BEXSERO. It was reported that, the patient was no longer experiencing a headache, vomiting or fever at the time reporting, but was just a little nauseous. No further information was provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On 31-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L027070, expiry date: 30-APR-2017). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to a patient of unspecified age and gender. Concurrent conditions and medical history were not reported. On 23-MAY-2016, the patient was inadvertently administered an expired dose of PEDVAXHIB with lot # J010383 and expiration date 21-MAY-2016, (strength, dose and route unspecified). No adverse effect was reported. Product quality complaint (PQC) was not involved. No further details were provided. Additional information has been requested.
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult female patient who received BOOSTRIX. On 6th June 2016, the patient received BOOSTRIX .5 ml. On 8th June 2016, 2 days after receiving BOOSTRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to BOOSTRIX. Additional details were provided as follows: This case was not previously reported to anyone. The reporter stated that, the patient experienced pain in arm, in arm opposite of vaccinated arm. Date of birth of the patient was unknown.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Dizziness, pallor and brief LOC for 20 seconds.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 21-year-old male patient who received MENVEO. Previously administered products included Tdap vaccine with an associated reaction of injection site pain. On 1st June 2016, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On 1st June 2016, less than one day after receiving MENVEO, the patient experienced injection site muscle pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site muscle pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site muscle pain and injected limb mobility decreased to be related to MENVEO. Additional details were provided as follows: This case was previously reported to a manufacturer. The reporter stated that, after vaccination with MENVEO the patient was still experiencing deep muscle pain on the inside. There were no injection site symptoms. The patient stated that, it was hard for him to move his arm when he wakes up in the morning and it took him time to where the pain loosens up. The morning was the worst. The patient is pretty athletic and active, but had not been able to perform regular exercises, like a push-up. His arm feels like day two or three and had not improved. The reporter, also stated that patient compared this experience to when he received the Tdap vaccine, in which he only experienced tenderness for two days before it subsided.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from an 82 year old female patient, reported on herself. The patient's medical history and concurrent conditions were not reported. On 25-MAY-2016, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot# and expiry date not reported). Concomitant medications included unspecified blood pressure medication. On approximately 01-JUN-2016 (reported as 1 week after vaccination), the patient developed 3 bumps on her left breast (breast mass), she then noticed one on her back and rear buttocks, and on the side of left arm. The patient sought medical attention and had received unspecified treatment. The outcome of the events was reported as not recovered. The reported did not assess the relatedness between the events and ZOSTAVAX. No product quality complain (PQC) involved. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning an adult patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 18-MAY-2016, the patient was inadvertently vaccinated with a pediatric dose of RECOMBIVAX HB, 5/0.5 microgram (mcrg)/ml, lot # M022077, expiration date 10-MAR-2019 (route unspecified). No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via two company representatives refers to a female patient of unknown age. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M000592, route of administration reported as "intramuscular or subcutaneous injection", (dose, strength and expiry date were not reported). On an unknown date, the patient experienced "injection site swelling after being administered PNEUMOVAX 23". No treatment was given for the event. No lab diagnostics studies were performed. The outcome of injection site swelling was reported as recovered, on an unknown date. The patient sought medical attention by contacting doctor's office. The relatedness between the event and PNEUMOVAX 23 was not reported. The physician requested a lot check. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unspecified age and gender. Concurrent conditions and medical history were unspecified. On an unspecified date in May 2016 (reported as last week), the patient was inadvertently vaccinated with a dose of PEDVAXHIB (strength, dose, dose# and route unspecified) instead of the intended dose of MENACTRA. No adverse effects were reported. No product quality complaint (PQC)was involved. No further information was provided. Additional information is not expected as the reporter did not provide consent to follow-up.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Angioedema, Arthritis, Injection site reaction, Injection site swelling
Clinical narrative: Angioedema and swelling at Inj site, arthritis.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema, Skin warm
Clinical narrative: Edema, rubor, calor. Diphenhydramine 25 mg prn.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Abasia, Full blood count normal, Peripheral swelling
Clinical narrative: Swelling of leg; unable to walk.
Age: 0.2
Sex: F
Vaccine: HEPA
Symptoms: Irritability, Nodule, Pyrexia
Clinical narrative: This spontaneous report as received from a medical assistant refers to her 2-month-old (also reported as 4 months of age) daughter with no drug reaction nor allergies. The patient's medical history included acid reflux. In approximately March 2016 (reported as at her two month check up), the patient was inadvertently vaccinated with a dose of VAQTA (lot#, expiration date, dose, route and site of administration were not reported. Concomitant therapies included two other unspecified vaccines. In approximately 2016 (reported as at an unspecified time after the injection), the patient presented with a knot, fever and irritability. No lab diagnostics studies were performed. The patient was treated with unspecified dose of TYLENOL. The patient was doing alright at the time of this report. The outcome of events was not reported. The relatedness between knot, fever and irritability and VAQTA was not reported. Additional information has been requested.
Sex: F
Vaccine: HEPAB
Symptoms: Dysphagia, Headache, Injection site pain, Insomnia, Oropharyngeal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in an adult female patient who received TWINRIX adult. On an unknown date, the patient received TWINRIX adult. On an unknown date, an unknown time after receiving TWINRIX adult, the patient experienced headache, sore throat, swallowing difficult, injection site pain and difficulty sleeping. On an unknown date, the outcome of the headache, sore throat, swallowing difficult, injection site pain and difficulty sleeping were unknown. It was unknown if the reporter considered the headache, sore throat, swallowing difficult, injection site pain and difficulty sleeping to be related to TWINRIX adult. Additional details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The patient received a dose of TWINRIX adult and experienced headache, difficulty sleeping, throat soreness with difficulty swallowing and injection site arm soreness. The patient had denied permission to contact their physician and declined to answer questions for safety report.
Age: 71.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Area surrounding where PPSV 23 was administered is warm to touch, red, and painful. Pt's daughter s/s began in the evening after administration. Referred to PCP for treatment.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Face injury, Head injury, Syncope
Clinical narrative: Pt fine at administration but while at checkout had a syncopal episode. Pt hit head and chin at time of fall. Provider notified, legs lifted, BP monitored. Observed in office for 30 mins.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Rec'd 5 yr. immunizations 6/13/16 at office. Pt with S/S beginning 6/14/16 -> (Rt) upper arm with edema, erythema and warmth. Afebrile. Seen for S/S 6/16/16. Supportive care recommended - Ice packs, PRN BENADRYL and return PRN if increased.
Age: 1.18
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Metabolic function test, Pyrexia, Seizure
Clinical narrative: Pt was given vaccine on 6/14/16-reportedly had a seizure on 6/15/16 and went to ER. Pt was not seizing when seen, did have a fever of 38.7- was released as improved.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: Patient was given HPV while pregnant.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Patient was given HPV while pregnant.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. No information regarding the patient's medical history, concurrent condition and concomitant medication was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L025737, expiration date 28-JUL-2017; lot # M003659, expiration date 20-SEP-2017 (dose and route of administration were not reported). No adverse effects were reported. Data logger was involved. The vaccine lots were exposed to a temperature of 32.7 degrees Fahrenheit (F), time frame of excursion was reported as 4 hours and 54 minutes total cumulative time. There was no previous excursions. No product quality complaint (PQC) was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent condition and concomitant medication was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, lot # L020861, expiration date 25-JAN-2017; lot # L029617, expiration date 19-MAY-2017, orally (dose was not reported). No adverse effects were reported. Data logger was involved. The vaccine lots were exposed to a temperature of 32.7 degrees Fahrenheit (F), time frame of excursion was reported as 4 hours and 54 minutes total cumulative time. There was no previous excursions. No product quality complaint (PQC) was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent condition and concomitant medication was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # L015460, expiration date 20-JUL-2017; lot # M009377, expiration date 17-JUL-2017, (dose and route of administration were not reported). No adverse effects were reported. Data logger was involved. The vaccine lots were exposed to a temperature of 32.7 degrees Fahrenheit (F), time frame of excursion was reported as 4 hours and 54 minutes total cumulative time. There was no previous excursions. No product quality complaint (PQC) was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Syncope, Visual impairment
Clinical narrative: Patient reported dizziness, visual disturbances and faint after receiving MENVEO.
Age: 44.0
Sex: F
Vaccine: MMR, PPV
Symptoms: Erythema, Malaise, Nausea, Peripheral swelling
Clinical narrative: The day after receiving vaccines, arm was red and swollen and felt nauseous, "sick" for 1 week.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Feeling cold, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: About 10 hours after receiving immunization severe arm pain, neck and spine pain. About 24 hours after fatigue, 102 degree fever, and chills.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Spinal pain
Clinical narrative: About 10 hours after receiving immunization severe arm pain, neck and spine pain. About 24 hours after fatigue, 102 degree fever, and chills.
Age: 1.28
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Injection site swelling, Injection site vesicles, Lymphadenopathy
Clinical narrative: 6-6 = Bilat swelling thighs-blisters Rt thigh x 3-4 and bilat inj adenopathy, temp 100.6, added f/u Dr at the 13th  = reported increased LNS.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site induration, Injection site mass
Clinical narrative: 2 inch hard lump left deltoid.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 5 year old female patient. The patient's concurrent condition and medical history was not provided. On 09-JUN-2016, this morning, the patient was vaccinated an expired M-M-R II RHA, lot # K007108, exp date 16-MAY-2016, subcutaneously in the child's right quad. Concomitant therapy was not provided. The reporter stated there was no know side effects or other problems after administering the injection. No treatment was given. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: I injected patient in the Left Deltoid with MENACTRA and within a few seconds he passed out. He came back to within a few seconds. EMT came out and checked everything and he signed form not to go to hospital.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Loss of consciousness
Clinical narrative: I injected patient in the Left Deltoid with MENACTRA and within a few seconds he passed out. He came back to within a few seconds. EMT came out and checked everything and he signed form not to go to hospital.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, Mumps antibody test negative
Clinical narrative: Information has been received from a nurse concerning a 23 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 03-AUG-1994 and 01-JUL-1998, the patient received the first and second dose of M-M-R II (dose, unit, frequency, route, Lot # and expiration date unspecified), respectively. On an unspecified date, patient had "titers drawn", which showed she was not immune to mumps. She had been seen by the nurse. The patient was given a third dose of M-M-R II (dose, unit, frequency, and route not reported, Lot # L009545 and expiration date 19-MAR-2017, therapy type: RHA) on 09-JUN-2016 (extra dose administered). The outcome of the event and causal relationship between the event and M-M-R II were unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent condition and concomitant medication was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # L029467, expiration date 06-AUG-2017; lot # L041204, expiration date 20-Oct-2017; lot # L030160, expiration date 11-AUG-2017; lot # L048468, expiration date 02-DEC-2017, (dose and route of administration were not reported). No adverse effects were reported. Data logger was involved. The vaccine lots were exposed to a temperature of 20 degrees fahrenheit (F), time frame of excursion was reported as 4 days and 15 hours total cumulative time. There was no previous excursions. No product quality complaint (PQC) was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent condition and concomitant medication was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # L000877, expiration date 22-JUN-2017; lot # L033343, expiration date 13-SEP-2017, (dose and route of administration were not reported). No adverse effects were reported. Data logger was involved. The vaccine lots were exposed to a temperature of 32.7 degrees fahrenheit (F), time frame of excursion was reported as 4 hours and 54 minutes total cumulative time. There was no previous excursions. No product complaint (PQC) was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Cellulitis, Erythema, Local reaction
Clinical narrative: Local reaction within 12 hrs redness and increased x 1 1/2 days. Secondary cellulitis treated with KEFLEX 500 mg 1 tablet bid x 7 d.
Age: 11.0
Sex: F
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Red swollen area upper Left arm. Clindamycin, Diphenhydramine, Ibuprofen given.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Initial report received from a health care professional on 17 May 2010: This patient was vaccinated with MENVEO (Batch No. 028011) vaccine intramuscularly, on an unspecified date. On 08 May 2010, his patient was presented with pain at forearm with hand swelling after 24 hours of the vaccine administration at arm. The outcome of the events was reported as completely recovered on 12 May 2010. The seriousness and causality of the events was not reported.