chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Acupuncture, Injection site pain, Pain
Clinical narrative: Case number PHHY2016US041619, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 622219) website on 29 Mar 2016. This report refers to a 42-years-old female patient. Past medical history included acupuncture. Current conditions included cold and hurt with movement when trying to remove shirt/ cannot actually disrobe. Concomitant medications included SYNTHROID 0.05mg 4X per week. The patient was vaccinated with FLUVIRIN (batch number: 152805) intramuscularly in left arm on 01 Dec 2015. On 03 Dec 2015, the patient reported her arm and shoulder where the shot was administered began to hurt, pain became excruciating over next few weeks, could not move it without intense pain. The patient was treated with acupuncture, which decreased her pain from 10 to 3 (units unspecified), then it started to increase again over in next few days. It was reported that, after 2 and half months the pain had decreased although it hurt with number of movements including trying to remove shirt. The patient also reported that, she could barely put pressure from right arm to lift her left arm and felt that the pharmacist was not negligent while administering the flu shot. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious (reported as permanent disability). The causality of the events was not reported. Upon follow up, Quality Assurance department confirmed that reported batch number 152805 was not a valid batch number for FLUVIRIN, therefore the QA record for this batch number was cancelled. Follow up information report received from Quality Assurance department on 19 Apr 2016: Updated QA comments.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Arthralgia, Blood test, Decreased appetite, Fatigue, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer. A 74-years-old female patient received PREVNAR 13, via an unspecified route of administration on 03Dec2015 at single dose. Medical history included brain radiotherapy at the end of November, and ongoing chronic obstructive pulmonary disease (COPD). Concomitant medication included INVOKANA 300 mg ongoing, LIDALL 2 mg, propafenone 150 mg 3 times a day ongoing, ADVAIR twice a day ongoing, SPIRIVA twice a day ongoing, temazepam 30 mg once a day. The patient previously received an unspecified pneumococcal vaccine but her doctor thought that it was a good idea have PREVNAR 13 because she had COPD. On 10Dec2015, one week after vaccination the patient experienced fatigue, joint pain, lack of appetite, constant shaking, was tired, exhausted all with outcome of not recovered. The events were assessed as serious per hospitalization. She thought that the radiation to the brain might be the cause of shaking though she went to her radiation doctor and the doctor did blood work and everything was normal and the doctor said that the radiation was not the cause. Her family doctor had prescribed her XANAX, prednisone.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Arthralgia, Decreased appetite, Fatigue, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer. A 74-years-old female patient received PREVNAR 13, via an unspecified route of administration on 03Dec2015 at single dose. Medical history included brain radiotherapy at the end of November, and ongoing chronic obstructive pulmonary disease (COPD). Concomitant medication included INVOKANA 300 mg ongoing, LIDALL 2 mg, propafenone 150 mg 3 times a day ongoing, ADVAIR twice a day ongoing, SPIRIVA twice a day ongoing, temazepam 30 mg once a day. The patient previously received an unspecified pneumococcal vaccine but her doctor thought that it was a good idea have PREVNAR 13 because she had COPD. On 10Dec2015, one week after vaccination the patient experienced fatigue, joint pain, lack of appetite, constant shaking, was tired, exhausted all with outcome of not recovered. The events were assessed as serious per hospitalization. She thought that the radiation to the brain might be the cause of shaking though she went to her radiation doctor and the doctor did blood work and everything was normal and the doctor said that the radiation was not the cause. Her family doctor had prescribed her XANAX, prednisone.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Arthralgia, Blood test normal, Decreased appetite, Fatigue, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer. A 74-years-old female patient received PREVNAR 13, via an unspecified route of administration on 03Dec2015 at single dose. Medical history included brain radiotherapy at the end of November, and ongoing chronic obstructive pulmonary disease (COPD). Concomitant medication included INVOKANA 300 mg ongoing, LIDALL 2 mg, propafenone 150 mg 3 times a day ongoing, ADVAIR twice a day ongoing, SPIRIVA twice a day ongoing, temazepam 30 mg once a day. The patient previously received an unspecified pneumococcal vaccine but her doctor thought that it was a good idea have PREVNAR 13 because she had COPD. On 10Dec2015, one week after vaccination the patient experienced fatigue, joint pain, lack of appetite, constant shaking, was tired, exhausted all with outcome of not recovered. The events were assessed as serious per hospitalization. She thought that the radiation to the brain might be the cause of shaking though she went to her radiation doctor and the doctor did blood work and everything was normal and the doctor said that the radiation was not the cause. Her family doctor had prescribed her XANAX, prednisone.
Age: 74.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pneumothorax, Vaccination complication
Clinical narrative: Information has been received from a healthcare worker/practice manager referring to a 74 year old female patient with moderate asthma, abnormal glucose, hypertension and high cholesterol. The patient did not have a history of any allergies. On an unspecified date, (reported as "a long time ago"), the patient was vaccinated with PNEUMOVAX 23 (dose, route, Lot number were unspecified), concomitantly with an unspecified flu vaccine and developed an unspecified allergy that led to a collapsed lung. The patient had not recalled all the details about the experience including whether or not hospitalization was required or if this was considering life threatening or what diagnostic procedures might have been completed or medications employed. The outcome of the events was unknown. The relationship between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Hypersensitivity, Pneumothorax
Clinical narrative: Information has been received from a healthcare worker/practice manager referring to a 74 year old female patient with moderate asthma, abnormal glucose, hypertension and high cholesterol. The patient did not have a history of any allergies. On an unspecified date, (reported as "a long time ago"), the patient was vaccinated with PNEUMOVAX 23 (dose, route, Lot number were unspecified), concomitantly with an unspecified flu vaccine and developed an unspecified allergy that led to a collapsed lung. The patient had not recalled all the details about the experience including whether or not hospitalization was required or if this was considering life threatening or what diagnostic procedures might have been completed or medications employed. The outcome of the events was unknown. The relationship between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: TTOX
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse practitioner on 19 April 2016. This case involves a 12-year-old male patient who was vaccinated with a dose of TETANUS TOXOID (manufacturer: unknown, batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient is now 37 years old. The patient's pre-existing physician diagnosed allergies included horse serum allergy and birth defects, medical conditions was reported as not available. Illness at time of vaccination was reported as unknown. Concomitant medications were not reported. On unspecified date following the vaccination, the patient had experienced fever (105 degrees). On unspecified date, the patient was hospitalized. Other laboratory data was reported as unknown. The patient's corrective treatment was not reported. On unspecified date, the patient recovered from event. List of documents held by sender: none. Sender's Comments: This is a poorly documented case referring to a 37 years old male patient who at the age of 12 years received tetanus toxoid vaccine and experienced fever. Time to onset was not reported. Further information regarding the dates of administration of suspect vaccine and date of onset of the reported event were not provided, hence temporal association cannot be established. In this case very limited information was provided, no information regarding the concomitant medication, concurrent illness, course of hospitalization were provided. Considering the limited available information causality cannot be assessed.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Pain, Pyrexia
Clinical narrative: Fever, chills, body ache, redness at site.
Age: 1.6
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Body temperature fluctuation, Decreased activity, Decreased appetite, Hyporesponsive to stimuli, Irritability
Clinical narrative: Says child had the PEDIARIX on Monday and feels like he is having a reaction to it. Says temp fluctuates up and down, getting up to about 102, says he is "sad", clingy, "lethargic". I asked what she meant by lethargic and she said just not active like usual and slower to respond, clingy, etc. Decreased appetite, drinking ok, esp when fever is down.
Age: 1.6
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Lethargy
Clinical narrative: Says child had the PEDIARIX on Monday and feels like he is having a reaction to it. Says temp fluctuates up and down, getting up to about 102, says he is "sad", clingy, "lethargic". I asked what she meant by lethargic and she said just not active like usual and slower to respond, clingy, etc. Decreased appetite, drinking ok, esp when fever is down.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Local reaction, Pain
Clinical narrative: Patient presented to the clinic Monday morning with a large local reaction. At the site of injection there was swelling the size of patient's palm, bruising and tenderness around the area. Patient complained of pain in moving and lifting arm. Pt states he iced it over the weekend with no relief.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact dates, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 22-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot number reported as 016966, expiration date: May 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reactions/allergies reported. Since January 2016 the patients were vaccinated with improperly stored doses of MMR II (lot # L026551 with expired date 16-JAN-2017, digital data logger, dose and route were unknown). No concomitant therapy was reported. The improperly stored vaccines were stored under 53.8 F for 4 hours and 48 minutes and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact dates, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 20-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot number reported as L07560, expiration date: June 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact dates, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 20-NOV-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot # K016966, expiration date: May 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. On unknown dates, unspecified patients were vaccinated with improperly stored VAQTA lot# L043209; expiration date 17-SEP-2017, dose and route of administration were unspecified. The vaccines had been exposed to 32 degrees Fahrenheit for 11 hours. There was no previous temperature excursion. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received 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 as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. On unknown dates, unspecified patients were vaccinated with improperly stored RECOMBIVAX HB lot# L038018; expiration date 13-AUG-2017, dose and route of administration were unspecified. The vaccines had been exposed to 32 degrees Fahrenheit for 11 hours. There was no previous temperature excursion. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Death
Clinical narrative: This is a spontaneous report from a non-contactable physician communicated to a Pfizer sales representative. An elderly female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single on unknown date. Medical history included that the patient was very sick. Concomitant medications were not reported. Very very very old patient received PREVNAR 13 and the next day, she passed away on an unspecified date. It was not reported if an autopsy was performed. Physician causality assessment: 100% sure that the PREVNAR 13 had nothing to do with the patient's passing. No follow-up attempts possible. No further information expected.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Actually vaccination time and adverse event time unknown as this was during a vaccination clinic located at a local middle school. It was reported that the client had a syncopal episode in the gymnasium after she had been vaccinated. The client recovered and returned to class after her parent was notified.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Swelling, redness, pain of the entire left arm, mild fever. There was some itching for the first few hrs. The swelling diminished gradually, took 5 days to go away.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Swelling, redness, pain of the entire left arm, mild fever. There was some itching for the first few hrs. The swelling diminished gradually, took 5 days to go away.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Inflammation, Peripheral swelling
Clinical narrative: Swollen, red and inflamed arm from shoulder to elbow.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Reddened, warm, tender welt at varicella injection site (LA)and low grade fever per mom. Was given TYLENOL at home that evening..   measured 4/22/16 @ 1530 at 7cm x 6 cm and raised, warm, remains tender to touch. Advised to continue TYLENOL as needed, warm compresses for comfort and anti-itch cream such as CALAMINE lotion if needed. Advised to go to ER for any facial/tongue/throat swelling, difficulty breathing, etc.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Reddened, warm, tender welt at varicella injection site (LA)and low grade fever per mom. Was given TYLENOL at home that evening..   measured 4/22/16 @ 1530 at 7cm x 6 cm and raised, warm, remains tender to touch. Advised to continue TYLENOL as needed, warm compresses for comfort and anti-itch cream such as CALAMINE lotion if needed. Advised to go to ER for any facial/tongue/throat swelling, difficulty breathing, etc.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Induration, Limb immobilisation, Rash, Skin discolouration, Skin warm
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received first dose of TRUMENBA, at single dose on an unspecified date. The patient medical history and concomitant medications were not reported. The patient reported various side effects such as: arm immobilization, hardness of the area (deltoid), warmness and develop dark spots in the left deltoid, all on an unspecified date. Patient visited her pediatrician and was informed to wait 4-5 days to observe progress. Eventually, the spots disappeared as well of other side effects. patient completely recovered from the events on an unknown date.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse reporting for 2 patients, and from a contactable physician via Pfizer Customer Service. This is the 1st of 2 reports. A 73-year-old male patient of an unspecified ethnicity started to receive PREVNAR 13 (Lot # M56417, Expiry Date Jun2017) intramuscular at 0.5 ml, single in the left deltoid on 24Mar2016 13:06. The patient medical history was not reported. The patient's concomitant medications were not reported. No other vaccine were given on same date along with suspected vaccine. No other vaccinations within 4 weeks prior. The patient experienced afebrile cellulitis on 24Mar2016, late that evening. The event afebrile cellulitis required an emergency room or doctor visit on 25Mar2016 and he came with redness and swelling. No hospital stay. The patient stated it started the night of the vaccination and the next morning it was more significant. The patient was treated with KEFLEX 500mg and it has resolved. On an unspecified date the patient recovered from the events.
Sex: F
Vaccine: TTOX
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Initial unsolicited report received from a nurse on 18 March 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Tetanus Vaccine (batch number, expiration date, dose, dose number, route and site of administration were reported as unknown) on an unspecified date in 2002 at another office. Patient's ongoing illness, medical history, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On an unspecified date in 2002, post vaccination, the patient experienced considerably enlarged lymph node in neck and pain in the lymph node on the side where she received the tetanus injection. Laboratory data and corrective treatment were not reported. The patient's outcome was not reported. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Dehydration, Pyrexia
Clinical narrative: Fever 107 Dehydrated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No patients' medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patients were vaccinated with a dose of GARDASIL lot # K007828, expiration date: 02-MAR-2017 (dates, doses and routes not reported), that was improperly stored. The vaccine was stored in temperature of 1.7 Celsius degree (C) for two hours and 5 minutes and of 1.7 C for 2 hours and 15 minutes. There was no previous temperature excursion. The excursion was captured with the use of Digital Data Logger. No adverse effects were reported. This is one of several report received from the same source. Additional information is not expected as the nurse did not wish to be contacted.
Age: 74.0
Sex: M
Vaccine: TTOX
Symptoms: Gastric ulcer haemorrhage
Clinical narrative: Gastric ulcer with hemorrhage.
Age: 83.0
Sex: M
Vaccine: DTP
Symptoms: Rash
Clinical narrative: Rash.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, nausea, vomiting and COPD exacerbation.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Erythema, Hyperhidrosis, Hypersensitivity
Clinical narrative: Per various notes in chart: Comments: pt states she has started to develop a reaction from her second hep B injection. She has a rash and a fever of 102.4 she will come to walk in for eval. She is not having any problems breathing, sob, swelling in throat etc. Patient came to team II and reported that she had her second dose of Hepatitis B today (her at 0851) and started to feel dizzy at 1100 then her face started turning red and developed a rash on her jaw area. Will send to walk in clinic as provider has no available appts this time of day. Pt of Dr, no avail appts presents to walk in with c/o having an allergic reaction to her second Hep B vaccine, which was given here this morning at 9am, since then she has been lightheaded, dizzy, sweats, face getting red, and shaky. 29 year old female pt recd her 2nd immunization for hep B in the series and shortly thereafter developed hives, dizziness, mild shortness of breath. The hives have resolved and the only remaining finding is some mild erythema of the cheeks and submandibular area. Lung fields are clear bilaterally.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Rash, Tremor, Urticaria
Clinical narrative: Per various notes in chart: Comments: pt states she has started to develop a reaction from her second hep B injection. She has a rash and a fever of 102.4 she will come to walk in for eval. She is not having any problems breathing, sob, swelling in throat etc. Patient came to team II and reported that she had her second dose of Hepatitis B today (her at 0851) and started to feel dizzy at 1100 then her face started turning red and developed a rash on her jaw area. Will send to walk in clinic as provider has no available appts this time of day. Pt of Dr, no avail appts presents to walk in with c/o having an allergic reaction to her second Hep B vaccine, which was given here this morning at 9am, since then she has been lightheaded, dizzy, sweats, face getting red, and shaky. 29 year old female pt recd her 2nd immunization for hep B in the series and shortly thereafter developed hives, dizziness, mild shortness of breath. The hives have resolved and the only remaining finding is some mild erythema of the cheeks and submandibular area. Lung fields are clear bilaterally.
Age: 65.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Arthralgia, Myalgia
Clinical narrative: Myalgia and arthralgia.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not specified. On 08-APR-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L041204, expiry date: 20-OCT-2017 (dose, strength, dose number, vaccination site, route not provided). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of two reports from the same source. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Haematochezia, Haemorrhage, Nausea
Clinical narrative: Patient calls stating ever since I had those shots in the office I've been on the toilet with diarrhea, nauseated, abdominal discomfort - denies any fever but confirms bright blood in the stool.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Reddened area surrounding injection site no warmth to touch.
Age: 25.0
Sex: M
Vaccine: HEPA, IPV, MNQ, TYP, YF
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: 4-19-16 4PM (R) arm wrist to bicep. About 100 red raised "dots", itchy. Took BENADRYL and TYLENOL. 4-21-16 AM (L) arm wrist to bicep about 50 red raised "dots" itchy. Took BENADRYL and TYLENOL. (R) arm unchanged. 4-25-16 telecall to patient. Rash unchanged. Stats "always was itchy."
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. Since January 2016 the patient were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L038018 with expired date 13-SEP-2017, digital data logger, dose and route were unknown). No concomitant therapy was reported. The improperly stored doses of RECOMBIVAX HB (lot # L038018 with expired date 13-SEP-2017, digital data logger, dose and route were unknown). No concomitant therapy was reported. The improperly stored vaccines were stored under 53.8 F for 4 hours and 48 minutes. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician referring to a 14 year old female patient who on an unknown date enrolled in a market research program. There was no relevant medical history. In approximately 2009 the patient was vaccinated with her first dose of GARDASIL. There was no concomitant therapy. In 2009, the patient experienced dizziness. The patient did not faint but had to lie down. The blood pressure was normal in 10-15 minutes and she went home. The diagnostic tests were not performed. Action taken with GARDASIL was reported as continued since the event did not prevent administration of dose 2 and 3. The outcome of dizziness was reported as recovering. The reporter considered the event of dizziness to be not serious and related to GARDASIL. Additional information is not expected since the physician won't be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning 2 unspecified patients were administered improperly stored ZOSTAVAX (lot# L037790, expired date 30-DEC-2016, dose and route not reported) on multiple unspecified dates. These vaccines were stored under temperature -12 centigrade degree for 24 to 48 hours. The patients' concurrent condition, medical history and concomitant therapy was not reported. There was no previous temperature excursion. No adverse effects were reported. At the time of report, the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact dates, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 23-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot # L007560, expiration date: June 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Bursitis, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling in injection site, inflamed bursa, bursitis.
Age: 57.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Adult patient was given pediatric Dtap (Infanrix) instead of TDap (Boostrix).  No reaction to report.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Malaise, Seizure
Clinical narrative: Pt received vaccine stated that she didn't feel well and needed to lay down. Laid down and had an apparent seizure. Took BP and had an additional seizure EMS activate, took over care and transfered to Hospital.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mother had called the After hrs service, on 4/21/16- reported redness/swelling/pain where immunization given. Size of a softball. Hot and hard to touch.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, PNC13, VARCEL
Symptoms: No adverse event
Clinical narrative: No adverse event known.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Electrocardiogram normal, Full blood count normal, Gait disturbance, Metabolic function test normal, Muscular weakness
Clinical narrative: Sudden onset of sharp pain and weakness in both legs within 10 minutes of vaccine. Experienced lean to the left when walking but strength had returned by this time. Sent to the ED for evaluation.  Pain gone by the time she got there. Lasted 30 minutes at most.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Urine analysis normal
Clinical narrative: Sudden onset of sharp pain and weakness in both legs within 10 minutes of vaccine. Experienced lean to the left when walking but strength had returned by this time. Sent to the ED for evaluation.  Pain gone by the time she got there. Lasted 30 minutes at most.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact dates, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 23-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot # L007560, expiration date: June 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Age: 33.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site discharge, Injection site pain
Clinical narrative: Reported pain at injection site on right deltoid for 1 week began after Tdap shot also drainage occurred from injection site in the morning of 4/18/2016.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact dates, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 22-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot # K016966, expiration date: May 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old patient, gender unspecified. The patient's concurrent condition and medical history was not reported. On 20-AUG-2015, the patient was vaccinated with the first dose of GARDASIL (dose, lot number and route was not reported). The physician reported that the patient came in late for the second vaccination of GARDASIL and was administered the second dose on 19-MAR-2016 (inappropriate schedule of vaccine administration). No adverse effects reported. No further details provided. Additional information is not expected since the reporter did not wish further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No patients' medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patients were vaccinated with a dose of RECOMBIVAX HB lot number: K010216, expiration date: 17-SEP-2016 (thimerosal status not provided), lot number: L014419, expiration date: 15-APR-2017 (thimerosal status  not provided), lot number: J013394, expiration date: 25-AUG-2016 (thimerosal status not provided) (dates, doses and routes not reported), that were improperly stored. The vaccine was stored in temperature in 1.7 Celsius degree (C) for two hours and 5 minutes and in 1.7 C for 2 hours and 15 minutes. There was no previous temperature excursion. The excursion was captured with the use of Digital Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as the nurse did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to 2 patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored (Merck) VARIVAX doses (2 doses) (lot# L029472, expiry date 06-AUG-2017) (temperature: 9.3 Fahrenheit (F), time frame: 3.5 hours and data logger) (incorrect storage of drug). There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-SEP-1998, the patient was vaccinated with the first dose of LIQUID PEDVAXHIB (dose, lot # and expiration date were not reported, intramuscularly). On 20-NOV-1998 and on 18-JAN-1999, the patient received the second and the third dose of LIQUID PEDVAXHIB, respectively. Then, on 15-APR-2016, the patient received an additional dose of LIQUID PEDVAXHIB in error. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No patients' medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patients were vaccinated with a doses of PNEUMOVAX 23 lot number: K023328, expiration date: 23-JUN-2016 (dates, doses and routes not reported), that was improperly stored. The vaccine was stored in temperature of 1.7 Celsius degree (C) for two hours and 5 minutes and of 1.7 C for 2 hours and 15 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as the nurse did not wish to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact dates, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 19-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot # L007560, expiration date: June 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored (Merck) VARIVAX lot # L034367, expiration date- 08-SEP-2017 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature/Time frame was 6F/10 hours. Possibly 4 doses were administered but healthcare worker was unable to confirm. There was none previous temperature excursion. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. Since January 2016 the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L044526 with expired date 09-NOV-2017, digital data logger, dose and route were unknown). No concomitant therapy was reported. The improperly stored vaccines were stored under 30.2 F for 2 hours and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician referring to an unspecified number of 11-18 years old male patients, 1 in 100 who were enrolled in a patient support program. There was no information about medical history, concurrent condition and concomitant medication. On unknown dates the patients were vaccinated with first dose of GARDASIL (strength, dosage, frequency and route unspecified). Patients fainted when they received GARDASIL. Pediatrician would then have them elevate legs, recover, and watch the patients for 15-20 mins before letting them go. The physician reminded patients to eat before vaccine and had them sit in office for 15 (unit unspecified). The physician did not prevent administration of 2, 3 doses due to event. The outcome of syncope was reported as recovering/resolving. The causality was not reported. This is one of two cases received from the same reporter. Additional information is not expected as there was no consent to follow up.