chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA, MMR
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. The patient's pertinent medical history and drug reactions or allergies were not reported. On 21-AUG-2015, the patient was vaccinated with improperly stored doses of VAQTA (dose and route were not reported, lot # L009445, expiry date 01-JUN-2017) and M-M-R II (dose and route were not reported, lot # K024035, expiry date 26-NOV-2016). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No medical history, concurrent conditions or concomitant therapies were reported. On 28-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA lot # L009445, expiration date 01-JUN-2017 (dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from an office manager refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (lot # K026246, exp. date on 28-JAN-2017), (strength, route of administration and dose were not provided). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from an office manager refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of MMR II (lot # J016232, exp. date 19-DEC-2015), (strength, route of administration and dose were not provided). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from an office manager refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of ROTATEQ (lot # K023537, exp. date on 22-JUN-2016), orally, (strength and dose were not provided). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a physician referring two patients of unknown gender "in their twenties". Pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patients were vaccinated with RECOMBIVAX HB (Lot #, dose and route not reported). No concomitant therapies were reported. It was reported that the patients needed to be "revaccinated" with RECOMBIVAX HB after "losing immunity" (onset date not reported). It was unable to be confirmed whether either patient previously received any doses of RECOMBIVAX HB but it could not be ruled out. At the time of the report the patients outcome were unknown. Additional information has been requested (correspondence containing a request for additional information is scheduled).
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug ineffective, Herpes zoster
Clinical narrative: Information has been received from a pharmacist as part of a marketing research program, refers to an 84 year old female patient. The patient's concurrent conditions included: chronic obstructive pulmonary disease (COPD) or asthma. In June 2015 the patient was vaccinated with ZOSTAVAX (subcutaneous, strength, lot# and dose were unknown). Concomitant therapies included SPIRIVA. In June 2015 the patient got shingles and the reporter indicated the vaccine was lack of efficacy. The outcome of the events was reported as recovered/resolved in 2015. The reporter considered the events to be non-serious and not related to ZOSTAVAX. Additional information is not expected as the reporter refused to be contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from an office manager refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL (lot # J012212, exp. date on 18-FEB-2016), (strength, route of administration and dose were not provided). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash pruritic, Skin warm
Clinical narrative: Patient developed a large, hot, red, itchy rash that extended 7 inches down her arm and 6 inches around. She came into the pharmacy 9/16/15 and will take BENADRYL and apply ice.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 09-MAY-2015 and on 11-MAY-2015, the patient was vaccinated with the first and second dose of GARDASIL intramuscular (strength, dose, anatomical location, lot # and expiration date were not reported). On 14-SEP-2015, the patient was in the office to receive GARDASIL 9 as the third dose (strength, dose, anatomical location, lot # and expiration date were not reported) (interchange of vaccine products). There was not a product quality complaint involved. At the time of the report, the outcome the event was unknown. The relatedness of the adverse events and suspect therapy was not provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Significant localized reaction of left upper arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection area is warm, swollen, reddened and slightly bruised in a 1 1/2 x 2 inch oval area at the site. Advised to take her pain med of choice - TYLENOL, ibuprofen, apply ice packs, elevate arm.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Rash generalised
Clinical narrative: Per mom pt received 1 vaccine on 9-14-15 on 9-15-15 pt broke out in rash from head to toe. Went to urgent care given BENADRYL and steroids per mom.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from an office manager refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of PROQUAD (lot # L009209, exp. date on 17-SEP-2016), (strength, route of administration and dose were not provided). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness at the injection site. Pain at the injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from an office manager refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # L007225, exp. date on 03-MAR-2017), (strength, route of administration and dose were not provided). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse, refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 14-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L015046, expiration date 14-SEP-2015. No concomitant therapies were reported. No adverse effects were reported. Additional information is not expected, since there was no consent to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report has been received from an office manager refers to an unspecified number of patents of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VAQTA (lot # K026529, exp. date on 02-JUN-2017), (strength, route of administration and dose were not provided). There was no concomitant medication reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple patients of unknown age and gender. Informationn about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (lot # K011325 with expiration date of 08-APR-2017; strength, dosage, frequency and route unspecified) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were vaccinated with doses of improperly stored M-M-R II (lot # K021152 with expiration date of 02-NOV-2016; strength, dosage, frequency and route unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor, Posture abnormal, Vision blurred
Clinical narrative: 1-2 mins after vaccine she became dizzy, slumped over, unfocused, pale, color returned after 3 mins. BP normal.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Anaemia, Blood test, Fibromyalgia, Incorrect route of drug administration, Injection site pain
Clinical narrative: Initial unsolicited report received from a consumer on 01 September 2015. This case involves a 49-year-old female patient, who received a intramuscular second dose of IMOGAM (batch number was not reported, route and site of administration were not reported) and two doses of IMOVAX from which first dose was administered subcutaneously and second dose was not fully administered intramuscularly both on 12 September 2012. Patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. Other medical history and concomitant medications were not reported. On 15 September 2012, 3 days after vaccination with IMOGAM, patient became ill, was diagnosed with anemia and began to have pain which started in her bilat shoulders at administration site but then progressed to her full body. Patient was also diagnosed with fibromyalgia. It was a case of wrong vaccine administered (gave IMOGAM in error), vaccine underdose for IMOVAX (vaccine loss and some product remained in the syringe for which patient was called for revaccination), inappropriate route of vaccination for IMOVAX (one dose was give subcutaneously and one was given intramuscularly). Patient required ER/doctor visit. Laboratory investigations were not reported. Patient received iron administrations as corrective treatment and ongoing treatment with a rheumatologist and her primary provider. Patient had not recovered from the above reported events. Upon medical review, the case was considered as serious due to important medical event: fibromyalgia. Documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Laboratory test, Malaise, Pain, Underdose, Wrong drug administered
Clinical narrative: Initial unsolicited report received from a consumer on 01 September 2015. This case involves a 49-year-old female patient, who received a intramuscular second dose of IMOGAM (batch number was not reported, route and site of administration were not reported) and two doses of IMOVAX from which first dose was administered subcutaneously and second dose was not fully administered intramuscularly both on 12 September 2012. Patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. Other medical history and concomitant medications were not reported. On 15 September 2012, 3 days after vaccination with IMOGAM, patient became ill, was diagnosed with anemia and began to have pain which started in her bilat shoulders at administration site but then progressed to her full body. Patient was also diagnosed with fibromyalgia. It was a case of wrong vaccine administered (gave IMOGAM in error), vaccine underdose for IMOVAX (vaccine loss and some product remained in the syringe for which patient was called for revaccination), inappropriate route of vaccination for IMOVAX (one dose was give subcutaneously and one was given intramuscularly). Patient required ER/doctor visit. Laboratory investigations were not reported. Patient received iron administrations as corrective treatment and ongoing treatment with a rheumatologist and her primary provider. Patient had not recovered from the above reported events. Upon medical review, the case was considered as serious due to important medical event: fibromyalgia. Documents held by sender: none.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Irritability, Ultrasound scan normal, VIth nerve paralysis
Clinical narrative: This is a spontaneous report from a contactable medical assistant who called on behalf of a doctor. A 7-month-old female patient receive single doses of PREVNAR 13 at 0.5 ml, ROTATEQ at 2 ml, and PENTACEL at 0.5 ml, all were given via an unspecified route of administration on an unknown date on 12May2015 when the patient was 3-months-old. The patient's medical history was none. There were no concomitant medications. On an unknown date in 2015, the patient experienced right sixth nerve palsy in the eye, bulging fontanelle, and fever and things of that nature, fluffy (at night). It was reported that the patient who was going on 7-months-old was delayed the 6-month shot because the patient received the suspect products at the "4-month-old" appointment and experienced a week long side effect which began a few hours after the vaccinations. The patient developed fancy responses within a couple of hours that required holding the patient for six days and developed a bulging fontanelle and a right sixth nerve palsy. The patient underwent some testing and she saw a specialist for the sixth nerve palsy in the eye but there was nothing as far as the treatment that could be done other than TYLENOL for fever and things of that nature. No treatments were received for the event of right sixth nerve palsy in the eye. The patient saw an ophthalmologist who said that everything was normal, the eye was getting better and they did a head ultrasound that showed the "right macro cranial". The clinical outcome for the events was recovered in 2015 after six days. The reporting medical assistant reported, "They were thinking that the side effects were caused by the vaccines but they were not sure."
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Agitation, Fontanelle bulging, Inappropriate schedule of drug administration, Pyrexia, Ultrasound scan
Clinical narrative: This is a spontaneous report from a contactable medical assistant who called on behalf of a doctor. A 7-month-old female patient receive single doses of PREVNAR 13 at 0.5 ml, ROTATEQ at 2 ml, and PENTACEL at 0.5 ml, all were given via an unspecified route of administration on an unknown date on 12May2015 when the patient was 3-months-old. The patient's medical history was none. There were no concomitant medications. On an unknown date in 2015, the patient experienced right sixth nerve palsy in the eye, bulging fontanelle, and fever and things of that nature, fluffy (at night). It was reported that the patient who was going on 7-months-old was delayed the 6-month shot because the patient received the suspect products at the "4-month-old" appointment and experienced a week long side effect which began a few hours after the vaccinations. The patient developed fancy responses within a couple of hours that required holding the patient for six days and developed a bulging fontanelle and a right sixth nerve palsy. The patient underwent some testing and she saw a specialist for the sixth nerve palsy in the eye but there was nothing as far as the treatment that could be done other than TYLENOL for fever and things of that nature. No treatments were received for the event of right sixth nerve palsy in the eye. The patient saw an ophthalmologist who said that everything was normal, the eye was getting better and they did a head ultrasound that showed the "right macro cranial". The clinical outcome for the events was recovered in 2015 after six days. The reporting medical assistant reported, "They were thinking that the side effects were caused by the vaccines but they were not sure."
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: VIth nerve paralysis
Clinical narrative: This is a spontaneous report from a contactable medical assistant who called on behalf of a doctor. A 7-month-old female patient receive single doses of PREVNAR 13 at 0.5 ml, ROTATEQ at 2 ml, and PENTACEL at 0.5 ml, all were given via an unspecified route of administration on an unknown date on 12May2015 when the patient was 3-months-old. The patient's medical history was none. There were no concomitant medications. On an unknown date in 2015, the patient experienced right sixth nerve palsy in the eye, bulging fontanelle, and fever and things of that nature, fluffy (at night). It was reported that the patient who was going on 7-months-old was delayed the 6-month shot because the patient received the suspect products at the "4-month-old" appointment and experienced a week long side effect which began a few hours after the vaccinations. The patient developed fancy responses within a couple of hours that required holding the patient for six days and developed a bulging fontanelle and a right sixth nerve palsy. The patient underwent some testing and she saw a specialist for the sixth nerve palsy in the eye but there was nothing as far as the treatment that could be done other than TYLENOL for fever and things of that nature. No treatments were received for the event of right sixth nerve palsy in the eye. The patient saw an ophthalmologist who said that everything was normal, the eye was getting better and they did a head ultrasound that showed the "right macro cranial". The clinical outcome for the events was recovered in 2015 after six days. The reporting medical assistant reported, "They were thinking that the side effects were caused by the vaccines but they were not sure."
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Pyrexia, Ultrasound skull abnormal, VIth nerve paralysis
Clinical narrative: This is a spontaneous report from a contactable medical assistant who called on behalf of a doctor. A 7-month-old female patient receive single doses of PREVNAR 13 at 0.5 ml, ROTATEQ at 2 ml, and PENTACEL at 0.5 ml, all were given via an unspecified route of administration on an unknown date on 12May2015 when the patient was 3-months-old. The patient's medical history was none. There were no concomitant medications. On an unknown date in 2015, the patient experienced right sixth nerve palsy in the eye, bulging fontanelle, and fever and things of that nature, fluffy (at night). It was reported that the patient who was going on 7-months-old was delayed the 6-month shot because the patient received the suspect products at the "4-month-old" appointment and experienced a week long side effect which began a few hours after the vaccinations. The patient developed fancy responses within a couple of hours that required holding the patient for six days and developed a bulging fontanelle and a right sixth nerve palsy. The patient underwent some testing and she saw a specialist for the sixth nerve palsy in the eye but there was nothing as far as the treatment that could be done other than TYLENOL for fever and things of that nature. No treatments were received for the event of right sixth nerve palsy in the eye. The patient saw an ophthalmologist who said that everything was normal, the eye was getting better and they did a head ultrasound that showed the "right macro cranial". The clinical outcome for the events was recovered in 2015 after six days. The reporting medical assistant reported, "They were thinking that the side effects were caused by the vaccines but they were not sure."
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Hypermetropia, Irritability, Pseudostrabismus, Strabismus
Clinical narrative: This is a spontaneous report from a contactable medical assistant who called on behalf of a doctor. A 7-month-old female patient receive single doses of PREVNAR 13 at 0.5 ml, ROTATEQ at 2 ml, and PENTACEL at 0.5 ml, all were given via an unspecified route of administration on an unknown date on 12May2015 when the patient was 3-months-old. The patient's medical history was none. There were no concomitant medications. On an unknown date in 2015, the patient experienced right sixth nerve palsy in the eye, bulging fontanelle, and fever and things of that nature, fluffy (at night). It was reported that the patient who was going on 7-months-old was delayed the 6-month shot because the patient received the suspect products at the "4-month-old" appointment and experienced a week long side effect which began a few hours after the vaccinations. The patient developed fancy responses within a couple of hours that required holding the patient for six days and developed a bulging fontanelle and a right sixth nerve palsy. The patient underwent some testing and she saw a specialist for the sixth nerve palsy in the eye but there was nothing as far as the treatment that could be done other than TYLENOL for fever and things of that nature. No treatments were received for the event of right sixth nerve palsy in the eye. The patient saw an ophthalmologist who said that everything was normal, the eye was getting better and they did a head ultrasound that showed the "right macro cranial". The clinical outcome for the events was recovered in 2015 after six days. The reporting medical assistant reported, "They were thinking that the side effects were caused by the vaccines but they were not sure."
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Fontanelle bulging, Irritability, VIth nerve paralysis
Clinical narrative: This is a spontaneous report from a contactable medical assistant who called on behalf of a doctor. A 7-month-old female patient receive single doses of PREVNAR 13 at 0.5 ml, ROTATEQ at 2 ml, and PENTACEL at 0.5 ml, all were given via an unspecified route of administration on an unknown date on 12May2015 when the patient was 3-months-old. The patient's medical history was none. There were no concomitant medications. On an unknown date in 2015, the patient experienced right sixth nerve palsy in the eye, bulging fontanelle, and fever and things of that nature, fluffy (at night). It was reported that the patient who was going on 7-months-old was delayed the 6-month shot because the patient received the suspect products at the "4-month-old" appointment and experienced a week long side effect which began a few hours after the vaccinations. The patient developed fancy responses within a couple of hours that required holding the patient for six days and developed a bulging fontanelle and a right sixth nerve palsy. The patient underwent some testing and she saw a specialist for the sixth nerve palsy in the eye but there was nothing as far as the treatment that could be done other than TYLENOL for fever and things of that nature. No treatments were received for the event of right sixth nerve palsy in the eye. The patient saw an ophthalmologist who said that everything was normal, the eye was getting better and they did a head ultrasound that showed the "right macro cranial". The clinical outcome for the events was recovered in 2015 after six days. The reporting medical assistant reported, "They were thinking that the side effects were caused by the vaccines but they were not sure."
Age: 16.0
Sex: F
Vaccine: HPVX, HPV4, MNQ
Symptoms: Abnormal behaviour, Dizziness, Laboratory test normal, Syncope, Visual impairment
Clinical narrative: This spontaneous report as received from a physician refers to a non-pregnant 16 year old female patient with cerebral palsy, left sided hemiparesis and no drug reactions or allergies. The patient's medical history and concomitant medications were not reported. On 23-JUL-2010, the patient was vaccinated with a dose of MENACTRA, (dose, route of administration, injection site, lot number and expiration date were not reported). On 08-DEC-2014, the patient received a dose of GARDASIL, intramuscularly, lot number H011350, expiration date: 21-FEB-2015, (dose and injection site were not provided). On 14-AUG-2015, the patient was vaccinated with doses of GARDASIL, intramuscularly, lot number K010215, expiration date: 05-MAY-2017, (dose and injection site were not provided) and MENACTRA, (dose, route of administration, injection site, lot number and expiration date were not reported). On 17-AUG-2015, the patient developed blurry vision, light sensitivity and pain in the eyes. It was reported that the patient had sought medical attention. On 31-AUG-2015, the patient was admitted to the hospital where she received 1 dose of methylprednisolone (manufacturer unknown), intravenously (on an unspecified date). Laboratory diagnostic studies performed on an unknown date in 2015 included computerized tomography scan (CT), blood tests and magnetic resonance imaging (MRI) (no results were reported). On an unknown date in 2015, the patient was discharged from the hospital. On 05-SEP-2015, the patient experienced dizziness and fainted. The physician reported that the patient had recovered from the dizziness and fainting on the same day. The outcome of the events of blurry vision, light sensitivity and pain in the eyes was reported as not recovered/not resolved at the time of the report. The relatedness between the events and suspect therapies was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPVX, HPV4, MNQ
Symptoms: Blood test, Computerised tomogram, Dizziness, Eye pain, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from a physician refers to a non-pregnant 16 year old female patient with cerebral palsy, left sided hemiparesis and no drug reactions or allergies. The patient's medical history and concomitant medications were not reported. On 23-JUL-2010, the patient was vaccinated with a dose of MENACTRA, (dose, route of administration, injection site, lot number and expiration date were not reported). On 08-DEC-2014, the patient received a dose of GARDASIL, intramuscularly, lot number H011350, expiration date: 21-FEB-2015, (dose and injection site were not provided). On 14-AUG-2015, the patient was vaccinated with doses of GARDASIL, intramuscularly, lot number K010215, expiration date: 05-MAY-2017, (dose and injection site were not provided) and MENACTRA, (dose, route of administration, injection site, lot number and expiration date were not reported). On 17-AUG-2015, the patient developed blurry vision, light sensitivity and pain in the eyes. It was reported that the patient had sought medical attention. On 31-AUG-2015, the patient was admitted to the hospital where she received 1 dose of methylprednisolone (manufacturer unknown), intravenously (on an unspecified date). Laboratory diagnostic studies performed on an unknown date in 2015 included computerized tomography scan (CT), blood tests and magnetic resonance imaging (MRI) (no results were reported). On an unknown date in 2015, the patient was discharged from the hospital. On 05-SEP-2015, the patient experienced dizziness and fainted. The physician reported that the patient had recovered from the dizziness and fainting on the same day. The outcome of the events of blurry vision, light sensitivity and pain in the eyes was reported as not recovered/not resolved at the time of the report. The relatedness between the events and suspect therapies was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPVX, HPV4, MNQ
Symptoms: Photophobia, Syncope, Vision blurred
Clinical narrative: This spontaneous report as received from a physician refers to a non-pregnant 16 year old female patient with cerebral palsy, left sided hemiparesis and no drug reactions or allergies. The patient's medical history and concomitant medications were not reported. On 23-JUL-2010, the patient was vaccinated with a dose of MENACTRA, (dose, route of administration, injection site, lot number and expiration date were not reported). On 08-DEC-2014, the patient received a dose of GARDASIL, intramuscularly, lot number H011350, expiration date: 21-FEB-2015, (dose and injection site were not provided). On 14-AUG-2015, the patient was vaccinated with doses of GARDASIL, intramuscularly, lot number K010215, expiration date: 05-MAY-2017, (dose and injection site were not provided) and MENACTRA, (dose, route of administration, injection site, lot number and expiration date were not reported). On 17-AUG-2015, the patient developed blurry vision, light sensitivity and pain in the eyes. It was reported that the patient had sought medical attention. On 31-AUG-2015, the patient was admitted to the hospital where she received 1 dose of methylprednisolone (manufacturer unknown), intravenously (on an unspecified date). Laboratory diagnostic studies performed on an unknown date in 2015 included computerized tomography scan (CT), blood tests and magnetic resonance imaging (MRI) (no results were reported). On an unknown date in 2015, the patient was discharged from the hospital. On 05-SEP-2015, the patient experienced dizziness and fainted. The physician reported that the patient had recovered from the dizziness and fainting on the same day. The outcome of the events of blurry vision, light sensitivity and pain in the eyes was reported as not recovered/not resolved at the time of the report. The relatedness between the events and suspect therapies was not reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Chills, Myalgia, Neck pain, Ocular hyperaemia, Paraesthesia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myalgia in a 18-year-old male patient who received FLUARIX (batch number 7AJ5J, expiry date unknown). Co-suspect products included BEXSERO (batch number 148901A, expiry date unknown). On 3rd September 2015, the patient received FLUARIX quadrivalent and the 1st dose of BEXSERO. On 7th September 2015, 4 days after receiving FLUARIX quadrivalent, the patient experienced myalgia and chills. On 10th September 2015, the patient experienced neck pain, pain in arm, chest pain, tenderness, eye red and paresthesia. On an unknown date, the outcome of the myalgia and chills were recovered/resolved and the outcome of the neck pain and eye red were not recovered/not resolved and the outcome of the pain in arm, chest pain, tenderness and paresthesia were recovering/resolving. The reporter considered the myalgia, neck pain, pain in arm, chest pain, tenderness, eye red, chills and paresthesia to be possibly related to FLUARIX quadrivalent. Additional details were received as follows: On 10th September 2015, 7 days after receiving FLUARIX QIV, the patient experienced paresthesia, prickly pain on his chest and arms that hurts to touch, sore neck and red left eye. These events were resolving. The reporter stated that the patient had good DTR, but the sales representative did not know what DTR means. The sales representative was not certain that the patient was actually seen in office, but it was a possibility.
Age: 18.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Chest pain, Chills, Myalgia, Neck pain, Ocular hyperaemia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myalgia in a 18-year-old male patient who received FLUARIX (batch number 7AJ5J, expiry date unknown). Co-suspect products included BEXSERO (batch number 148901A, expiry date unknown). On 3rd September 2015, the patient received FLUARIX quadrivalent and the 1st dose of BEXSERO. On 7th September 2015, 4 days after receiving FLUARIX quadrivalent, the patient experienced myalgia and chills. On 10th September 2015, the patient experienced neck pain, pain in arm, chest pain, tenderness, eye red and paresthesia. On an unknown date, the outcome of the myalgia and chills were recovered/resolved and the outcome of the neck pain and eye red were not recovered/not resolved and the outcome of the pain in arm, chest pain, tenderness and paresthesia were recovering/resolving. The reporter considered the myalgia, neck pain, pain in arm, chest pain, tenderness, eye red, chills and paresthesia to be possibly related to FLUARIX quadrivalent. Additional details were received as follows: On 10th September 2015, 7 days after receiving FLUARIX QIV, the patient experienced paresthesia, prickly pain on his chest and arms that hurts to touch, sore neck and red left eye. These events were resolving. The reporter stated that the patient had good DTR, but the sales representative did not know what DTR means. The sales representative was not certain that the patient was actually seen in office, but it was a possibility.
Age: 18.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myalgia in a 18-year-old male patient who received FLUARIX (batch number 7AJ5J, expiry date unknown). Co-suspect products included BEXSERO (batch number 148901A, expiry date unknown). On 3rd September 2015, the patient received FLUARIX quadrivalent and the 1st dose of BEXSERO. On 7th September 2015, 4 days after receiving FLUARIX quadrivalent, the patient experienced myalgia and chills. On 10th September 2015, the patient experienced neck pain, pain in arm, chest pain, tenderness, eye red and paresthesia. On an unknown date, the outcome of the myalgia and chills were recovered/resolved and the outcome of the neck pain and eye red were not recovered/not resolved and the outcome of the pain in arm, chest pain, tenderness and paresthesia were recovering/resolving. The reporter considered the myalgia, neck pain, pain in arm, chest pain, tenderness, eye red, chills and paresthesia to be possibly related to FLUARIX quadrivalent. Additional details were received as follows: On 10th September 2015, 7 days after receiving FLUARIX QIV, the patient experienced paresthesia, prickly pain on his chest and arms that hurts to touch, sore neck and red left eye. These events were resolving. The reporter stated that the patient had good DTR, but the sales representative did not know what DTR means. The sales representative was not certain that the patient was actually seen in office, but it was a possibility.
Age: 1.11
Sex: M
Vaccine: MMR
Symptoms: Crying, Decreased appetite, Measles post vaccine, Pyrexia, Rash erythematous
Clinical narrative: Inconsolable crying, decreased appetite, fever to 103, staring episodes, and red measles rash. This lasted for three weeks and involved five office visits to address patient's ill health.
Age: 1.11
Sex: M
Vaccine: MMR
Symptoms: Staring
Clinical narrative: Inconsolable crying, decreased appetite, fever to 103, staring episodes, and red measles rash. This lasted for three weeks and involved five office visits to address patient's ill health.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Hypoaesthesia
Clinical narrative: Woke up in AM on 09/02/15 with numbness in left hand/thumb. That night had numbness in right leg. On 09/04/15 had numbness in right hand with H/A and burning sensation on head. All symptoms gone by 09/07/15.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Pt felt shortness of breath. Chest pain. Condition resolved after approximately 10-15 min. Cleared by EMT.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: I experienced muscle aches, fever, chills, exhaustion.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Rash
Clinical narrative: Rash and pain. Not horribly significant, but I figured this information might be helpful to someone tracking the affects of the vaccine. I feel fine otherwise, and don't feel it is a problem at this time.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Body temperature increased, Hyperhidrosis
Clinical narrative: Started bad at school, When she came home she had gotten in bed.  Temp was 101.  Later that night 103.  Given Tylenol.  2 AM temp was 102.  This morning she was soaked, but fever has not returned.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Whole upper arm swelled up and became red from elbow to shoulder - inside and outer arm. At time reporterd-no swelling or redness at all.
Age: 1.27
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rash vesicular
Clinical narrative: Red blister type rash over hands arms legs feet-none on face no fever.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Nodule, Pain
Clinical narrative: (L) arm received flu vaccine 9/15/15. C/o pain, can't life arm & "knot" underarm.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Encephalopathy, Headache, Neck pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of encephalopathy in a 39-year-old female patient who received BOOSTRIX (batch number B7PC3, expiry date 12th September 2016). Concurrent medical conditions included sulfonamide allergy (caused rash), allergic reaction to antibiotics (use of MACROBID caused rash) and allergic reaction to antibiotics (AUGMENTIN). Concomitant products included DEPO-PROVERA. On 10th August 2015, the patient received BOOSTRIX .5 ml. On 3rd September 2015, 24 days after receiving BOOSTRIX, the patient experienced encephalopathy (serious criteria hospitalization and GSK medically significant), dizziness (serious criteria hospitalization), neck pain (serious criteria hospitalization) and headache (serious criteria hospitalization). On an unknown date, the outcome of the encephalopathy, dizziness, neck pain and headache were recovering/resolving. It was unknown if the reporter considered the encephalopathy and headache to be related to BOOSTRIX. The reporter considered the dizziness and neck pain to be possibly related to BOOSTRIX. Additional details were provided as follows: The BOOSTRIX was given in left deltoid. The patient was hospitalized for four days. She was doing much better, but still had some slight headaches and dizziness.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: After receiving the FLUVIRIN (MDV) vaccine, the patient's arm display erythema, red/raised circle around injection site approximately 2 inches in diameter and warm to the touch. Patient does not report pain or discomfort.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: She had redness, itchy and warm feeling below the injection site it started shortly after the vaccination went away for a while and came back the next day. Has redness down the arm, warm to touch & some itching.
Age: 60.0
Sex: M
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Erythema, Headache, Peripheral swelling, Pyrexia
Clinical narrative: Arm swollen and red, fever and headache. Not itching.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea
Clinical narrative: Pt described having headache & nausea after getting flu shot. Called the pharmacy 5 days after having had flu shot. Not sure if it's from flu shot or other underlying condition.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness
Clinical narrative: Initial unsolicited report received from a nurse on 08 September 2015. This case involves a 66-year-old male patient who was vaccinated with an intramuscularly dose (dose and dose series not reported) of FLUZONE HD (batch number UI428AA, expiry date 18 March 2016), in the left deltoid on 03 September 2015. Illness at time of vaccination was reported as not applicable. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as hypertension (HTN), arthritis, and remote history of prostate cancer (CA). Concomitant medications were not reported. On 03 September 2015, same day following the vaccination, the patient visited the ENT specialist for acute hearing loss. It was not indicated if the hearing loss was unilateral or bilateral, or how soon after the vaccination it was noted, but was stated as soon after the vaccination. It was reported that, patient required emergency room/doctor visit. Lab data included and corrective treatment was not reported. At the time of this report, the patient had not recovered from the event. Upon medical review, the case was considered as serious due to important medical event: acute hearing loss. List of documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Blood test normal, Discomfort, Dry skin, Hair disorder
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received a single dose of PREVNAR 13, via an unspecified route of administration at the age of 73-years on 06Mar2015. Medical history included blood pressure, thyroid disorder and she took levothyroxine for that, diverticulitis from 2013 and she did not take any medication for it. She had that attack in 2013. Concomitant medications included lisinopril, levothyroxine and TYLENOL. The patient might have polymyalgia rheumatica on an unspecified date with outcome of unknown, she had all kind of pain/ache all over on 11Mar2015 with outcome of unknown, shot pain never left in her shoulder but that was minor/pain went on from her elbow to then her shoulder on 11Mar2015 with outcome of not recovered, pain in both arm from her wrist and elbow on 11Mar2015 with outcome of unknown, little bit of stuck blood in her eye on an unspecified date with outcome of unknown, lost her weight around 18 pound on an unspecified date with outcome of unknown, she had gained weight on an unspecified date with outcome of unknown, she got perm in her hair it did not take for first time/hair were like straw on an unspecified date with outcome of unknown, finger nails are short, stubby, break off and now they were in layers on an unspecified date with outcome of unknown, skin was dry on an unspecified date with outcome of unknown, pain in both arm from her wrist and elbow on 11Mar2015 with outcome of unknown. Therapeutic measures were taken as a result of had all kind of pain/ache all over, shot pain never left in her shoulder but that was minor/pain went on from her elbow to then her shoulder, pain in both arm from her wrist and elbow, pain in both arm from her wrist and elbow. The patient mentioned that she went to doctor and they run some blood work in Aug2015. She mentioned that her doctor gave her TYLENOL for discomfort. The patient mentioned that she went to her rheumatologist and he put her on prednisone. She was trying to wean herself off of that because of dangerous effects of that and TYLENOL for the pain she was having from PREVNAR 13. The patient also mentioned that her rheumatologist told her that might be it was polymyalgia rheumatica.