chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Pyrexia, Skin warm, Vomiting
Clinical narrative: 103.4 fever; vomiting; arm hot to the touch; bright red - cellulitis - on meds AUGMENTIN 400 BID.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Pallor, Rash papular
Clinical narrative: (L) anterior thigh 23 cm x 8 cm bright erythematous, blanching, papular rash. No streaking, warmth, TTP, or edema. No treatment.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Rash, Tenderness
Clinical narrative: Arm swollen and redness. Tender to touch. Looks like a rash in area.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Pain in extremity
Clinical narrative: Patient had sore arm, bursitis of shoulder, 2 weeks continuously since flu shot administered.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: PNEUMOVAX site became swollen by 3PM, by 8PM whole arm was swollen. Treated with cold compression and elevation. By Thursday morning symptoms began to resolve.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Notified by parent on 10/27 pm of marked swelling of upper arm along with some redness and itching, mild discomfort. No sig. pain, no fever, no induration. (Swelling had started same day as vaccine).
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Notified by nurse triage on 10/27 at 8:15 pm that family was calling due to continued swelling and redness on leg at site of flu shot. No fever, no induration. Recommended cool compresses, pain med if needed, call office in AM for eval if worsening.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Malaise, Mass, Pyrexia, Skin warm
Clinical narrative: Within 2 hours, large egg-sized lump, hot to touch. Daily temperature (fever) for twelve days from 9/10 of a degree above normal (114 12 days) to 3 degrees above. Headache 14 days. General Malaise.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Pt. presented with a red rash on her left arm above her elbow that was warm to the touch.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Impetigo, Injection site erythema, Injection site inflammation, Rash, Varicella
Clinical narrative: Half dollar sized red inflamed area at inj. site. Impetigo/rash areas: A) Under nose, right nostril. B) Site RXN at inj. site. C) Various "pox" spots on left hand, forearm, and bicep.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Pallor, Urticaria
Clinical narrative: One hour after receiving flu vaccine, pt. developed generalized hives, dizziness and was pale. Pt. was taken to ER, given BENADRYL.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Received vaccine around 3 pm. She left pharmacy and then called back around 7 pm complaining of an intense pain running from the arm receiving the injection up to her neck. She says it began minutes after injection. Advised patient to seek medical help.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Fever 101.2 six hours after vaccination. Body aches.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Asthenia, Chills, Decreased appetite, Depressed mood, Diarrhoea
Clinical narrative: This spontaneous report was received from a 45 year old patient refers to himself. The patient had no pertinent medical history and no drug reactions or allergies. There was no concomitant therapy provided. On 02-AUG-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB intramuscular (dose, lot # and expiration date were not reported). On an unknown date, the patient experienced chills, diarrhea, flu type aches, slight fever, itching on both hands and feet that lasted a week. On 09-SEP-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB  intramuscular (strength, dose, lot # and expiration date were not reported). In approximately 2016, after the second dose of RECOMBIVAX HB the patient experienced the same previous symptoms along with, fatigue, blurred vision, headaches and he was unable to lie on his side due to the headaches. The patient also stated that in approximately 2016, had a loss of appetite, vomiting and joint pains. The patient sought medical attention by visiting his physician. The physician ran a series of unspecified tests, but could not give a specific diagnosis for the adverse events, therefore, was no specific treatment given. The patient stated that his symptoms have last for over 30 days in total. The outcome of chills, diarrhea, flu type aches, slight fever, itching on both hands and feet, fatigue, blurred vision, loss of appetite, vomiting, joint pains, headaches, and inability to lie on his sides die to the headaches was reported as not recovered. The relatedness between the outcome of chills, diarrhea, flu type aches, slight fever, itching on both hands and feet that lasted a week, fatigue, blurred vision, loss of appetite, vomiting, joint pains, headaches and RECOMBIVAX HB  was not reported. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Full blood count, Impaired work ability, Metabolic function test, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a 45 year old patient refers to himself. The patient had no pertinent medical history and no drug reactions or allergies. There was no concomitant therapy provided. On 02-AUG-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB intramuscular (dose, lot # and expiration date were not reported). On an unknown date, the patient experienced chills, diarrhea, flu type aches, slight fever, itching on both hands and feet that lasted a week. On 09-SEP-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB  intramuscular (strength, dose, lot # and expiration date were not reported). In approximately 2016, after the second dose of RECOMBIVAX HB the patient experienced the same previous symptoms along with, fatigue, blurred vision, headaches and he was unable to lie on his side due to the headaches. The patient also stated that in approximately 2016, had a loss of appetite, vomiting and joint pains. The patient sought medical attention by visiting his physician. The physician ran a series of unspecified tests, but could not give a specific diagnosis for the adverse events, therefore, was no specific treatment given. The patient stated that his symptoms have last for over 30 days in total. The outcome of chills, diarrhea, flu type aches, slight fever, itching on both hands and feet, fatigue, blurred vision, loss of appetite, vomiting, joint pains, headaches, and inability to lie on his sides die to the headaches was reported as not recovered. The relatedness between the outcome of chills, diarrhea, flu type aches, slight fever, itching on both hands and feet that lasted a week, fatigue, blurred vision, loss of appetite, vomiting, joint pains, headaches and RECOMBIVAX HB  was not reported. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Pyrexia, Weight decreased
Clinical narrative: This spontaneous report was received from a 45 year old patient refers to himself. The patient had no pertinent medical history and no drug reactions or allergies. There was no concomitant therapy provided. On 02-AUG-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB intramuscular (dose, lot # and expiration date were not reported). On an unknown date, the patient experienced chills, diarrhea, flu type aches, slight fever, itching on both hands and feet that lasted a week. On 09-SEP-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB  intramuscular (strength, dose, lot # and expiration date were not reported). In approximately 2016, after the second dose of RECOMBIVAX HB the patient experienced the same previous symptoms along with, fatigue, blurred vision, headaches and he was unable to lie on his side due to the headaches. The patient also stated that in approximately 2016, had a loss of appetite, vomiting and joint pains. The patient sought medical attention by visiting his physician. The physician ran a series of unspecified tests, but could not give a specific diagnosis for the adverse events, therefore, was no specific treatment given. The patient stated that his symptoms have last for over 30 days in total. The outcome of chills, diarrhea, flu type aches, slight fever, itching on both hands and feet, fatigue, blurred vision, loss of appetite, vomiting, joint pains, headaches, and inability to lie on his sides die to the headaches was reported as not recovered. The relatedness between the outcome of chills, diarrhea, flu type aches, slight fever, itching on both hands and feet that lasted a week, fatigue, blurred vision, loss of appetite, vomiting, joint pains, headaches and RECOMBIVAX HB  was not reported. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Arthralgia, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: This spontaneous report was received from a 45 year old patient refers to himself. The patient had no pertinent medical history and no drug reactions or allergies. There was no concomitant therapy provided. On 02-AUG-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB intramuscular (dose, lot # and expiration date were not reported). On an unknown date, the patient experienced chills, diarrhea, flu type aches, slight fever, itching on both hands and feet that lasted a week. On 09-SEP-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB  intramuscular (strength, dose, lot # and expiration date were not reported). In approximately 2016, after the second dose of RECOMBIVAX HB the patient experienced the same previous symptoms along with, fatigue, blurred vision, headaches and he was unable to lie on his side due to the headaches. The patient also stated that in approximately 2016, had a loss of appetite, vomiting and joint pains. The patient sought medical attention by visiting his physician. The physician ran a series of unspecified tests, but could not give a specific diagnosis for the adverse events, therefore, was no specific treatment given. The patient stated that his symptoms have last for over 30 days in total. The outcome of chills, diarrhea, flu type aches, slight fever, itching on both hands and feet, fatigue, blurred vision, loss of appetite, vomiting, joint pains, headaches, and inability to lie on his sides die to the headaches was reported as not recovered. The relatedness between the outcome of chills, diarrhea, flu type aches, slight fever, itching on both hands and feet that lasted a week, fatigue, blurred vision, loss of appetite, vomiting, joint pains, headaches and RECOMBIVAX HB  was not reported. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Headache, Influenza like illness, Pruritus, Pyrexia, Vision blurred
Clinical narrative: This spontaneous report was received from a 45 year old patient refers to himself. The patient had no pertinent medical history and no drug reactions or allergies. There was no concomitant therapy provided. On 02-AUG-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB intramuscular (dose, lot # and expiration date were not reported). On an unknown date, the patient experienced chills, diarrhea, flu type aches, slight fever, itching on both hands and feet that lasted a week. On 09-SEP-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB  intramuscular (strength, dose, lot # and expiration date were not reported). In approximately 2016, after the second dose of RECOMBIVAX HB the patient experienced the same previous symptoms along with, fatigue, blurred vision, headaches and he was unable to lie on his side due to the headaches. The patient also stated that in approximately 2016, had a loss of appetite, vomiting and joint pains. The patient sought medical attention by visiting his physician. The physician ran a series of unspecified tests, but could not give a specific diagnosis for the adverse events, therefore, was no specific treatment given. The patient stated that his symptoms have last for over 30 days in total. The outcome of chills, diarrhea, flu type aches, slight fever, itching on both hands and feet, fatigue, blurred vision, loss of appetite, vomiting, joint pains, headaches, and inability to lie on his sides die to the headaches was reported as not recovered. The relatedness between the outcome of chills, diarrhea, flu type aches, slight fever, itching on both hands and feet that lasted a week, fatigue, blurred vision, loss of appetite, vomiting, joint pains, headaches and RECOMBIVAX HB  was not reported. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a 45 year old patient refers to himself. The patient had no pertinent medical history and no drug reactions or allergies. There was no concomitant therapy provided. On 02-AUG-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB intramuscular (dose, lot # and expiration date were not reported). On an unknown date, the patient experienced chills, diarrhea, flu type aches, slight fever, itching on both hands and feet that lasted a week. On 09-SEP-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB  intramuscular (strength, dose, lot # and expiration date were not reported). In approximately 2016, after the second dose of RECOMBIVAX HB the patient experienced the same previous symptoms along with, fatigue, blurred vision, headaches and he was unable to lie on his side due to the headaches. The patient also stated that in approximately 2016, had a loss of appetite, vomiting and joint pains. The patient sought medical attention by visiting his physician. The physician ran a series of unspecified tests, but could not give a specific diagnosis for the adverse events, therefore, was no specific treatment given. The patient stated that his symptoms have last for over 30 days in total. The outcome of chills, diarrhea, flu type aches, slight fever, itching on both hands and feet, fatigue, blurred vision, loss of appetite, vomiting, joint pains, headaches, and inability to lie on his sides die to the headaches was reported as not recovered. The relatedness between the outcome of chills, diarrhea, flu type aches, slight fever, itching on both hands and feet that lasted a week, fatigue, blurred vision, loss of appetite, vomiting, joint pains, headaches and RECOMBIVAX HB  was not reported. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from a 45 year old patient refers to himself. The patient had no pertinent medical history and no drug reactions or allergies. There was no concomitant therapy provided. On 02-AUG-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB intramuscular (dose, lot # and expiration date were not reported). On an unknown date, the patient experienced chills, diarrhea, flu type aches, slight fever, itching on both hands and feet that lasted a week. On 09-SEP-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB  intramuscular (strength, dose, lot # and expiration date were not reported). In approximately 2016, after the second dose of RECOMBIVAX HB the patient experienced the same previous symptoms along with, fatigue, blurred vision, headaches and he was unable to lie on his side due to the headaches. The patient also stated that in approximately 2016, had a loss of appetite, vomiting and joint pains. The patient sought medical attention by visiting his physician. The physician ran a series of unspecified tests, but could not give a specific diagnosis for the adverse events, therefore, was no specific treatment given. The patient stated that his symptoms have last for over 30 days in total. The outcome of chills, diarrhea, flu type aches, slight fever, itching on both hands and feet, fatigue, blurred vision, loss of appetite, vomiting, joint pains, headaches, and inability to lie on his sides die to the headaches was reported as not recovered. The relatedness between the outcome of chills, diarrhea, flu type aches, slight fever, itching on both hands and feet that lasted a week, fatigue, blurred vision, loss of appetite, vomiting, joint pains, headaches and RECOMBIVAX HB  was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9, HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This father reports that this 12 year old female patient was initiated on either GARDASIL at an unknown dose or GARDASIL-9 at an unknown dose administered "in her arm" on 06-JUL-2016. The father states that he is unsure whether the patient has been receiving GARDASIL or GARDASIL-9 and that he just has "GARDASIL" in his notes. The father states the patient has no medical conditions or concomitant medications. The patient's second GARDASIL or GARDASIL-9 injection was given on 09-SEP-2016. The father states that on 29-SEP-2016, the patient's mother took her to her annual physical and he is unsure if any laboratory tests were performed at this time. The father states that during the annual physical on 29-SEP-2016 that a Hepatitis B vaccine and another dose of GARDASIL or GARDASIL-9 vaccine was ordered. The father states that since the patient does not like shots, she requested to only receive one shot during her visit. Because of this the patient given a third GARDASIL or GARDASIL-9 shot "in her arm" on 29-SEP-2016, which is an off-label dosing separation between the second and third doses. The father reports that the third GARDASIL or GARDASIL-9 shot had actually been scheduled for January 2017. On 29-SEP-2016 the patient was not given a Hepatitis B vaccination. The father reports that as of 11-OCT-2016, the patient has not experienced any adverse effects from the early third GARDASIL or GARDASIL-9 vaccination. The father reports that he confirmed today, 11-OCT-2016, that the patient received the GARDASIL or GARDASIL-9  on 29-SEP-2016, and that he had discussed the situation with the nurse practitioner. The nurse practitioner stated that the patient should not experience side effects from the early third injection, but that she will need an additional GARDASIL or GARDASIL- dose at the correct time. The father reports that he is seeking a second opinion. The father explains that the patient has not received any type treatment for the early third dose of the vaccine. As of 11-OCT-2016, the patient has received three doses of either GARDASIL or GARDASIL-9 on 06-JUL-2016, 09-SEP-2016 and 29-SEP-2016 and the outcome of the off-label separation between the second and third doses of the vaccination is unknown. When asked for the Lot number and expiration date of the product administered, this information was unknown to the father. Consent was given to contact the prescribing physician.
Age: 65.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Unevaluable event
Clinical narrative: Pt did not show any signs of distress, reactions, or changes in when he arrived. Monitor SXS.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Odynophagia, Oropharyngeal pain, Proctalgia, Vaccination complication
Clinical narrative: HPV - 1st dose c/o rectal pain severe and went to E.R. - no findings reported. HPV - 2nd dose c/o severe throat pain and pain with swallowing - went to physician and was told it was reaction to HPV and not to get 3rd dose.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Abdominal pain upper, Diarrhoea, Hyperhidrosis, Vomiting
Clinical narrative: Stomach pain, diarrhea, sweating, vomiting.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Pyrexia, Skin mass, Skin warm
Clinical narrative: Fever 102.4. Very warm to touch. Lump beneath skin per pt. Reddened area per pt 11cm x 6.5cm. No oozing. No abscess. Pain at injection site. Upon visit today pt reports no fever, pain better. Given AUGMENTIN XR x 8 days and xray.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: X-ray
Clinical narrative: Fever 102.4. Very warm to touch. Lump beneath skin per pt. Reddened area per pt 11cm x 6.5cm. No oozing. No abscess. Pain at injection site. Upon visit today pt reports no fever, pain better. Given AUGMENTIN XR x 8 days and xray.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Chills, Diarrhoea, Dizziness
Clinical narrative: Severe adverse affect after vaccine the next day. Vaccine given August 2, 2016. Felt like stomach was upset one hour later, then felt better but I did not eat. On Weds, Aug. 3, at 3:00 p.m. I had severe abdominal pain, so terrible that I had to lie down. Then, it felt like a knife passing through my intestines with diarrhea for about 5 hours. This was different pain than regular diarrhea cramping. So sick I could not sit up on toilet. Felt like throwing up at same time but did not. Was finally able to go to bed with terrible chills for 2 hours. It was 90 degrees outside this day. My husband or none of my family had been ill, nor did any of my family get sick from me. I was only one who received the vaccine. My husband ate and did everything I did before the vaccine, he did not receive the vaccine and was never sick. I felt ill for about 10 days. I went to Dr. and took sample of diarrhea because it looked like body tissue, Dr. said I had gastro intestinal flu. I believe my illness was caused by the vaccine. I did not see my regular doctor because he was out of the office that day (August 9, 2016 at 1:00 p.m.). Dizziness was also present and continues off and on to this day 10-24-16. The dizzy spells occurred the 2nd day when I became very ill.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Gastroenteritis viral, Malaise, Nausea
Clinical narrative: Severe adverse affect after vaccine the next day. Vaccine given August 2, 2016. Felt like stomach was upset one hour later, then felt better but I did not eat. On Weds, Aug. 3, at 3:00 p.m. I had severe abdominal pain, so terrible that I had to lie down. Then, it felt like a knife passing through my intestines with diarrhea for about 5 hours. This was different pain than regular diarrhea cramping. So sick I could not sit up on toilet. Felt like throwing up at same time but did not. Was finally able to go to bed with terrible chills for 2 hours. It was 90 degrees outside this day. My husband or none of my family had been ill, nor did any of my family get sick from me. I was only one who received the vaccine. My husband ate and did everything I did before the vaccine, he did not receive the vaccine and was never sick. I felt ill for about 10 days. I went to Dr. and took sample of diarrhea because it looked like body tissue, Dr. said I had gastro intestinal flu. I believe my illness was caused by the vaccine. I did not see my regular doctor because he was out of the office that day (August 9, 2016 at 1:00 p.m.). Dizziness was also present and continues off and on to this day 10-24-16. The dizzy spells occurred the 2nd day when I became very ill.
Age: 69.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: PREVNAR received on Wed, began to redden on Sun, on Mon was itchy and hard, symptoms resolved spontaneously on Thursday following. No medical attention, but did use topical BENADRYL.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Acne, Erythema, Rash
Clinical narrative: Two small bumps/pimple like, slight redness. Treated with ZYRTEC Children Allergy.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Rash pruritic
Clinical narrative: Dull headache x 3 days. Starting Saturday night 10/22/16. Had flu vaccine around 2:20 pm. C/O itchy rash to the torso and right arm three days after flu shot.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Infectious mononucleosis, Mononucleosis heterophile test positive, Oropharyngeal pain
Clinical narrative: Patient complained of fatigue and sore throat. Was diagnosed with mono on 09-19-16 by doctor.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant and therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD which undergone a temperature excursion (lot # M007961 and expiration date 15-AUG-2017; dose was unknown) subcutaneously in the back of the arm. The patient did not experience any adverse reactions. It was unknown if there was any relevant laboratory data. At the time of reporting, it was unknown if the patient continued to receive PROQUAD. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: DTAP, HEPA, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-JUN-2016, the patient was vaccinated with improperly stored VAQTA (lot # L048456, expiration date: 25-MAY-2017; dose and route of administration were not provided). On the same day, the patient was also vaccinated with DAPTACEL and ACTHIB. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: DTAP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-JUN-2016, the patient was vaccinated with improperly stored VAQTA (lot # L048456, expiration date: 25-MAY-2017; dose and route of administration were not provided). On the same day, the patient was also vaccinated with M-M-R II, VARIVAX, PREVNAR, DAPTACEL and ACTHIB. No adverse effect was 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: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient' medical history, concurrent conditions and concomitant medication were unknown. On 18-OCT-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # M013156, expiration date 15-OCT-2017, 1 injection, intramuscular). No adverse reaction was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided.  On unknown dates, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD lot # M014301, expiration date 22-SEP-2017; dose and route were unknown). No adverse effects were reported. The excursion temperature included 9.9 Fahrenheit degree for 30 minutes on 10-AUG-2016 and 24.4 Fahrenheit degree for 1 hour and 30 minutes on 25-AUG-2016. Data logger was involved. No product quality complaint (PQC) was involved. Additional information had been requested.
Age: 1.08
Sex: U
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 13 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-JUN-2016, the patient was vaccinated with improperly stored VAQTA (lot # L048456, expiration date: 25-MAY-2017; dose and route of administration were not provided). On the same day, the patient was also vaccinated with M-M-R II, VARIVAX and PREVNAR. No adverse effect was 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: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first excursion was 24, 34 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 176, 48 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD, lot # M007961, expiration date: 15-AUG-2017, subcutaneously in the back of the arm, (dose and dose number were not specified). There were no concomitant medications reported. It was stated that the vaccine had undergone a temperature excursion (no further details provided). The patient did not experience any adverse reactions. At the time of the report, it was unknown if the patient continued to receive PROQUAD. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 04-OCT-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L021609, expiry date 19-SEP-2016) subcutaneously (strength, dosing details, anatomical location were unknown). No adverse effects were reported. No product quality complaint was involved. 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 Licensed practical nurse refers to a multiple unspecified patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored (at a temperature of 9C for 24 hours) RECOMBIVAX HB, lot # L014878 (17-JAN-2018) (dosage not reported). No adverse effects reported. No data logger. No Product Quality Complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLUX, PER, UNK, VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report was received from a 55 year old female patient regarding herself. The patient had diabetes, thyroid and high blood pressure. The patient had AUGMENTIN allergy. On 24-OCT-2016, the patient was vaccinated with ZOSTAVAX and unspecified flu, hepatitis C and whooping cough vaccines. On 24-OCT-2016, the patient reported that the area around injection site became red on the evening. It started out small and got larger since 25-OCT-2016. The affected area looked like a welt and was the size of a small apple. The area was red, itchy and uncomfortable. The outcome of the events were unknown. No lab tests were performed. The patient did not seek medical attention. 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 (R.N.), concerning a 7 years old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not informed. It was reported that on an unknown date, the patient was inadvertently vaccinated with a dose of GARDASIL 9 lot # M017983, expiration date 30-MAY-2018 (dosage and therapy route were not provided). Concomitant therapies were not informed. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Injection site haemorrhage, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a consumer referring to her 87 years old mother with asthma. The patient's drug reactions/allergies and concomitant therapy were not reported. On approximately 13-OCT-2016 (reported as about 11 days ago), the patient received PNEUMOVAX 23 injection (lot #, expiration date, dose and route were unknown). Within a few hours of the administration, the patient developed itching around injection site. There was no swelling or redness around injection site, but it felt like that itching was from inside out. It was also little bit sore around injection site. The patient had been scratching the itchy area a lot and some bleeding of skin occurred. The patient had called physician. Unspecified treatment was given for the events. The outcome of the events was reported as not recovered. The causality assessment was not reported. Additional information is not expected as there is no consent for follow up.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 30-JUL-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first excursion was 24, 34 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 176, 48 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2017) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first excursion was 24, 34 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 176, 48 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age. On 14-OCT-2016, the patient was vaccinated with an expired dose of M-M-R II (lot # K016154, expiration date 24-SEP-2016, route and dose not reported). Nurse stated the M-M-R II in question did not have any previous temperature excursions. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a multiple unspecified patients of an unknown age and gender. The patients' relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored (at a temperature of 9C for 24 hours) GARDASIL 9, lot # L024993 (expiry date: 17-OCT-2017) and lot# L044475 (expiry date: 12-MAY-2017) (dosage not reported). No adverse effects reported. No data logger. No Product Quality Complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-OCT-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K007244, expiration date 16-MAR-2016). This specified lot number was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 176 hours with the highest recorded temperature of 48 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD which undergone a temperature excursion (lot # M007961 and expiration date 15-AUG-2017; dose was unknown) subcutaneously in the back of the arm. The patient did not experience any adverse reactions. It was unknown if there was any relevant laboratory data. At the time of reporting, it was unknown if the patient continued to receive PROQUAD. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report was received from an adult, pregnant female patient of an unknown age (reported as "almost 40 years of age") who was reporting on herself. The patient was scheduled to receive and unspecified TDAP vaccine on 29-SEP-2016, but she was administered a dose of unidentified Merck HPV vaccine reported as GARDASIL or GARDASIL 9 (dose, route of administration, lot # and expiration date not reported) in error instead of the TDAP. The patient was 28 weeks pregnant (in her third trimester) at the time of vaccine exposure. Her Last Menstrual Period (LMP) date was calculated (by subtracting the number of weeks of pregnancy from the date of vaccination) to be 17-MAR-2016 and her estimated delivery date (EDD) was 22-DEC-2016. Pregnancy outcome was pending and fetal outcome was unknown. The patient learned of this error at an unspecified time during the week of 17-OCT-2016. The administration error was discovered when the medical office listed in this case was doing a routine inventory of their vaccinations. The inventory "was off". The office traced the error "back to the patient's chart" and contacted the patient. No adverse reaction was reported. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain upper, Headache, Skin irritation
Clinical narrative: This spontaneous report was received from a 21 years old male patient regarding himself. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patient received first dose of GARDASIL, intramuscular injection (dosing details not reported). On 14-OCT-2016, after receiving GARDASIL the patient experienced pounding headaches, arm irritation and stomach pain. The patient sought medical attention by contacting the physician. No treatment was given for the events. Outcome of the events was reported as recovered. Causality of the events was not reported. No product quality complaint was involved. 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 other health professional refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9, lot # L036301 and expiry date: 20-DEC-2017, lot # M016193 and expiry date: 24-APR-2018. No concomitant medications were reported. The vaccine was exposed to a temperature frame of 34.5 Fahrenheit for 100 minutes. A data logger was involved. There were no previous excursions. No adverse events were reported. No product quality complaint was involved. This is one of several reports 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 physician refers to unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified dates since 01-SEP-2016, the patients received improperly stored doses of VARIVAX (lot # M023384, expiry date: 11-MAY-2018). Physician reported that the vaccine underwent temperature excursion at -11.9C for 3 hours and 52 minutes. There were no previous temperature excursion. A data logger was used to record temperatures. No adverse effects were reported. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from an office administrator refers to a 15 year old patient. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 03-AUG-2016, the patient was vaccinated with third dose of GARDASIL 9 (lot # M007764, expiry date: 30-JAN-2018) via intramuscular route. Reporter stated that the patient received their first and second dose of the vaccine (lot # L044475, expiry date: 12-MAY-2017 and lot # M005714, expiry date: 03-OCT-2017) on 25-MAR-2016 and 09-JUN-2016, respectively. The patient did not experience an adverse experience. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 23-JAN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL, lot # J009788 with expiration date of 17-MAR-2016 (strength, dose and route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the reported temperature excursion lasted 472 hours, where the lowest recorded temperature was 26 F (-3.333333333 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to two unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. Since 20-SEP-2016, 2 doses of improperly-stored doses of varicella virus vaccine live (dose and route were unknown; lot number was L050957 with expiration date 17-DEC-2017) were administered to two unspecified patients on unspecified dates. No adverse experience was reported. The temperature excursion was -3 centigrade degree for 2 hours and 15 minutes. There was no previous temperature excursion. This report was for data logger. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 32 year old female patient. The patient's relevant medical history, current conditions, concomitant medications and past drug history were not reported. On 14-OCT-2016 the patient was vaccinated with an expired dose of M-M-R II lot # K016154, expiration date: 24-SEP-2016. The patient has not reported any adverse effects. It was unknown if there was any relevant lab work. As of 15-OCT-2016, it was unknown if the patient would continue on the M-M-R II. The outcome of receiving an expired dose of M-M-R II was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 06-FEB-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 56 hours, with the highest recorded temperature of 53 degrees Fahrenheit (11.66 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.