chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-JUN-2015, the patient was vaccinated with the first dose of VAQTA (strength, lot# and expiration date were unknown, 0.5 ml) intramuscularly. On 06-JUN-2015, only about 5 weeks after his first dose, the patient was vaccinated with the second dose of VAQTA (strength, lot# and expiration date were unknown, 0.5 ml) intramuscularly. No adverse effects reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Rash generalised
Clinical narrative: Information has been received from a 78 year old female patient referring to herself. The patient's concurrent condition included high blood pressure, hypothyroidism, very low immune system and allergy to penicillin (unspecified), DEMEROL, and ALEVE. The patient's medical history included acid reflux. On 23-JUN-2015 the patient was vaccinated with ZOSTAVAX (dose and lot # were not reported, once, subcutaneous). Concomitant therapies included SYNTHROID and atenolol. On 26-JUN-2015, (also reported as 3 to 4 days after the vaccination), the patient became very nauseous. On 30-JUN-2015 (reported as a week later), the patient had rash like bumps on her body and the rash lasted over a week. An unspecified over the counter anti itch cream was given as treatment. No lab diagnostics studies were performed. The patient had not sought medical attention. The outcome of the events was reported as recovering. Additional information is not expected because there was no patient or physician's contact information.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with GARDASIL lot # K023423, expiration date 18-JUN-2016 (dose was not reported). The patient received a dose of GARDASIL that was stored improperly. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness, Injection site pain, Malaise, Mobility decreased
Clinical narrative: Extreme soreness in upper deltoid of left arm. Unable to lift arm above plane of shoulder. Following day experienced severe flu like symptoms. Resolved by the second day after the vaccination.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Vaccination site swelling
Clinical narrative: AN UNSPECIFIED TIME AFTER RECEIVING VACCINE PATIENT HAD SWELLING AND ITCHING AROUND THE VACCINE SITE. THE SWELLING SUBSIDED, BUT AFTER 2 WEEKS THE ITCHING REMAINS.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Seizure, Urinary incontinence
Clinical narrative: Approximately 5 minutes after vaccine was given, child was noted to have urinated on himself while sitting in a chair, and then began to have a seizure.  Child has no previous history of seizure activity.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Blister, Insomnia, Pruritus generalised, Pyrexia, Rash
Clinical narrative: First I noticed a red spot on my son's face and then he ran a fever in the afternoon before his afternoon nap. While I was changing his diaper I noticed red spots appearing in front of his body, stomach region and a large blister on his anus.  The next day blisters started appearing more at least 5 spots. There was a blister with fluid on it on his back. The following day that was when I decided to call to get him in to the ped's office because more blisters where forming all over his body and he had a low grade temperature. At least now 50 blisters on his body by the 3rd day 7/9/2015.  No treatment was given by the ped's office.  Was told that the illness is mild chickenpox outbreak due to the vaccine and should resolved in a week.  By the evening, more blisters appeared (at least 50 plus blisters on his face).  Blisters have been forming at the strangest places.  Terrible.  My son wasn't able to sleep at night and he has been itchy all over.  Today, I have given him bath in the morning and bath last night before dinner. Now, I am making a report on the adverse reaction to the MMRV vaccine my son received 3 days ago on 7/7/2015 at his 12 months well check.  Please advise what action will be taken.  Thank you.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Rash erythematous, Varicella post vaccine
Clinical narrative: First I noticed a red spot on my son's face and then he ran a fever in the afternoon before his afternoon nap. While I was changing his diaper I noticed red spots appearing in front of his body, stomach region and a large blister on his anus.  The next day blisters started appearing more at least 5 spots. There was a blister with fluid on it on his back. The following day that was when I decided to call to get him in to the ped's office because more blisters where forming all over his body and he had a low grade temperature. At least now 50 blisters on his body by the 3rd day 7/9/2015.  No treatment was given by the ped's office.  Was told that the illness is mild chickenpox outbreak due to the vaccine and should resolved in a week.  By the evening, more blisters appeared (at least 50 plus blisters on his face).  Blisters have been forming at the strangest places.  Terrible.  My son wasn't able to sleep at night and he has been itchy all over.  Today, I have given him bath in the morning and bath last night before dinner. Now, I am making a report on the adverse reaction to the MMRV vaccine my son received 3 days ago on 7/7/2015 at his 12 months well check.  Please advise what action will be taken.  Thank you.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: Patient given #2 HPV, and felt ok, no dizziness, moved to chair from exam table so brother could get his vaccines.  Patient had no complaints. Sibling finished with vaccines, and patient complains of dizziness.  She immediately fainted and body did have muscle contractions.  Patient did immediately open eyes.  Assisted patient to exam table to lie down, propped knees with pillow.  Placed cool cloth on forehead, offered orange juice.  BP taken 112/76.  Patient allowed to rest for 15 mins.  No further complaints, feels better.  BP rechecked 100/61.  Patient assisted to sitting position in which she sat for 3 min before brought to standing position.  She still feels no further symptoms.  Recommended to walk slowly with assistance.  Have food when arrive home, and call with any further questions or concerns.  Mom and patient verbalized understanding.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Neck mass, Pharyngeal oedema, Swollen tongue, Urticaria
Clinical narrative: Hives, swollen throat and tongue. A lump on his neck. Treatment included 5ml of Benadryl and injection of Epi-Pen Jr. Activated EMS and was taken to the ER after 20 mins of the reaction.
Age: 0.24
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash
Clinical narrative: MOTHER REPORTED A SMALL RASH IN THE FOREHEAD OF THE CHILD.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Local reaction
Clinical narrative: Localized reaction: Patient reported vaccine initially stung and remained sore, pain for initial 3 days after receiving vaccine, erythema started 4 days after receiving vaccine. Treated with doxycycline 100mg twice daily for 7 days.
Age: 1.87
Sex: F
Vaccine: DTAP
Symptoms: Speech disorder
Clinical narrative: Psychological and Speech.  Speech became progressively worse over the months.  Tried to explain all this to the doctor at her 2 yr. old appt. in December of 2014 and was made to feel like I was being paranoid. I had to practically beg for a referral to see a specialist. I stated that she had REVERTED! She is currently in Speech Therapy, with a moderate to severe diagnoses.  We attend therapy twice a week.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Blood culture negative, CSF test normal, Epstein-Barr virus test negative, Herpes simplex, Meningitis aseptic
Clinical narrative: Aseptic meningitis.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Viral test negative
Clinical narrative: Aseptic meningitis.
Age: 8.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test negative, Herpes zoster, Immune system disorder, Nerve injury, Rash
Clinical narrative: After taking 60mg of Prednisone a day for 7 days starting on June 25 2015 and going down to 40mg of Predisone a day for three days for auditory nerve damage caused by a viral infection, the patient developed a painful rash starting on the back and spreading to the chest and face, reaching its peak on July 7, 2015. The rash became pustules and traced along the right side of the face around the eye and caused puffiness along the cheek. Tests for allergic reactions proved negative, and it was determined and diagnosed as shingles from a weakened immune system. Patient was placed on Valtrex for 10 days and a recheck was scheduled for July 23, 2015. The only exposure to the herpes zoster virus was determined to be the chicken pox shot. Temperature and blood pressure was normal.
Age: 8.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular, Swelling face, Viral infection
Clinical narrative: After taking 60mg of Prednisone a day for 7 days starting on June 25 2015 and going down to 40mg of Predisone a day for three days for auditory nerve damage caused by a viral infection, the patient developed a painful rash starting on the back and spreading to the chest and face, reaching its peak on July 7, 2015. The rash became pustules and traced along the right side of the face around the eye and caused puffiness along the cheek. Tests for allergic reactions proved negative, and it was determined and diagnosed as shingles from a weakened immune system. Patient was placed on Valtrex for 10 days and a recheck was scheduled for July 23, 2015. The only exposure to the herpes zoster virus was determined to be the chicken pox shot. Temperature and blood pressure was normal.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Finding related to left upper arm, a 12 x 13 cm area of increased warmth and erythema left deltoid region. Central punctum noted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies reported. On 18-JUN-2015 the patients were vaccinated with improperly stored PROQUAD (Merck) (lot number K020747 and expiry date 30-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with PROQUAD (Merck) was unknown. The outcome of the events to the therapy with PROQUAD (Merck) was unknown. The relatedness of the events to the therapy with PROQUAD (Merck) was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Mom called office 7/9/15 stating left thigh has an area that looks like a mosquito bite directly on injection site. Area is red and warm to the touch. The redness is increasing in size. Mom said area stayed red after injection given 6-29-15.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: Indurated injection site 10x5 cm, warm.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, since 12-JUN-2015, the unspecified number of patients were administered an unspecified number of improperly stored doses of GARDASIL (lot # K005881, expiration date 14-JAN-2017), intramuscularly (dose, frequency, indication were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies reported. On 18-JUN-2015 the patients were vaccinated with improperly stored PROQUAD (Merck) (lot number L005295 and expiry date 17-AUG-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with PROQUAD (Merck) was unknown. The outcome of the events to the therapy with PROQUAD (Merck) was unknown. The relatedness of the events to the therapy with PROQUAD (Merck) was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 15 anonymous patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patients were vaccinated with PEDVAXHIB lot # K025005, expiration date 07-JUN-2017 (dose was not reported). The patients received a doses of PEDVAXHIB that was stored improperly. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent conditions or medical history was reported. On an unknown date the patients were vaccinated with VARIVAX (Merck) (lot # L00456, dose and route of administration not provided) that may have been improperly stored for the month of June 2015. No adverse symptoms was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from same reporter link (1507USA004343). Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. Since an excursion in February 2015, unspecified number of patients, on unspecified date, were vaccinated with doses of GARDASIL (lot # J006850, expiration date 31-MAR-2015) (route not reported), which have been exposed to temperature outside of the recommended range also reported as improperly stored vaccines. No concomitant medications were reported. No adverse effect (AE) had been observed or reported. Follow up information has been received from the Registered Nurse on 11-JUN-2015. During a follow up phone call attempt, the nurse stated that they were unable to share any patient information as they would need the patient to sign a consent form. A telephone call was received from the registered nurse on 22-JUN-2015, who stated that she had knowledge of two improperly stored doses of GARDASIL that were administered to two different patients. Follow up information has been received from the Registered Nurse on 02-JUL-2015. The nurse practitioner sent information regarding to the 12 year old patient who was vaccinated with GARDASIL (lot # J006850, expiration date 31-MAR-2016). This is on of two reports received from the same reporter. (MARRS # 1505USA002946) General tab, patient and narrative were updated.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and referred to an unspecified number of patients of unknown age and sex. On an unknown date, the unspecified number of patients may have received improperly stored PNEUMOVAX 23 (lot #, expiration date, strength, dose and frequency were not reported). No adverse effects were reported. This is one of four reports received from the same source. 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 registered nurse and referred to an unspecified number of patients of unknown age and sex. On an unknown date, the unspecified number of patients may have received improperly stored VARIVAX (Merck) (lot #, expiration date, strength, dose and frequency were not reported) injection. No adverse effects were reported. This is one of four reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and referred to an unspecified number of patients of unknown age and sex. On an unknown date, the unspecified number of patients may have received improperly stored PEDVAXHIB (lot #, expiration date, strength, dose and frequency were not reported). No adverse effects were reported. This is one of four reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: DTOX
Symptoms: Headache, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling pain and redness at injection site with blister at injection site.  Left arm swollen hand to shoulder.  Left hand and elbow numbness and pain. Unable to use left arm until 48 hours past injection.  Headache for duration.
Age: 14.0
Sex: F
Vaccine: DTOX
Symptoms: Injection site vesicles, Musculoskeletal disorder, Peripheral swelling
Clinical narrative: Swelling pain and redness at injection site with blister at injection site.  Left arm swollen hand to shoulder.  Left hand and elbow numbness and pain. Unable to use left arm until 48 hours past injection.  Headache for duration.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Dizziness, weakness, and fatigue.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Injection site pain, Pyrexia, Skin warm
Clinical narrative: Pain at a "7" in right thigh where shot administered. No swelling or redness. Mild fever-didn't take, but my skin was abnormally warm. Very tired. Fever gone by 7/10/15 @ 5pm. Pain & tiredness starting to go away now 7/10/15 @ 8:30pm. I am a RN. The nurse did administer the shot correctly.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Headache, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Patient states right after getting the shot she felt lightheaded and by evening had body aches and a headache that continued the next day and today has a "bump the size of an orange" at injection site and it itched this AM-but does not now. Advised ice packs and TYLENOL for comfort.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Chills, Erythema, Induration, Mobility decreased
Clinical narrative: 7-8-15 had severe upper back pain, unable to move (L) arm, muscle aches. 7-11-15 c/o (L) deltoid is hard, red, tender to touch with chills.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Tenderness
Clinical narrative: 7-8-15 had severe upper back pain, unable to move (L) arm, muscle aches. 7-11-15 c/o (L) deltoid is hard, red, tender to touch with chills.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Nine days after vaccine 7-10-15 noted red raised rash on face, arms, trunk. Worse on trunk. 7-9-15 pt. may have had slight fever. No itching. Went on antibiotics the day after vaccines which was 7-2-15. Mom does not think rash is related to antibiotics.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Blepharospasm, Blister, Erythema, Muscle spasms
Clinical narrative: Approximately 10 hours after receiving vaccine patient felt muscle cramps in legs, eye twitching, red ears, and developed blisters on hands and soles of feet. He took BENADRYL which seemed to help and reported to health center two days after.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema
Clinical narrative: 7-10-15 office visit. Client reports that ZOSTAVAX (given on 7-7-15) has caused redness and discomfort (L) upper arm. (L) upper arm appears red and warm to touch from injection area to just below elbow. Client states (L) arm seems better today. Medical referral made.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient describes intermittent pain at injection site in arm. She received dose of FLUZONE in November 2014 and is still having dull pain in arm. She has not had to seek treatment.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial report was received from a registered nurse referring to a patient of an unknown age. Concurrent conditions were not reported. On 26-JUN-2015, the patient received an improperly stored dose with PROQUAD (Merck), (Lot # 008354, expiration date 9-NOV-2016), (dose and route were not reported). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 10-APR-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 72 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. The healthcare professional informed that the total excursion time for this lot was 63 hours. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. In approximately 2015 (reported as since 13-MAR-2015), the patient were vaccinated with doses of ROTATEQ lot# K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. The healthcare professional informed that the total excursion time for this lot was 63 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information was received from a Medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender who on 14-APR-2015, the patient was vaccinated with a dose of ROTATEQ lot # K011663 (expiration date, dose, route and site of administration were not reported) that was exposed to temperatures outside of the recommended range. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fatigue, Injection site pain, Nausea, Pyrexia
Clinical narrative: 07/09/2015 mild other Patient had fever of 101, nausea, fatigue and pain in upper right arm. Patient started on KEFLEX to provide coverage if infection present.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 14-APR-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K00696 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 72 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 15-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours, This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Muscular weakness, Pain in extremity, Rash, Swelling
Clinical narrative: Vaccine given 6/23/15 in left arm at 10:26 am. Pt seen in urgent care on 6/28/15 complaining of left arm pain, muscle weakness and rash. Seen by PCP on 7/10/15 redness and swelling has improved after antibiotics.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 14-APR-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 72 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 15-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information was received from a Medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender who on 21-APR-2015, the patient was vaccinated with a dose of ROTATEQ lot # K011663 (expiration date, dose, route and site of administration were not reported) that was exposed to temperatures outside of the recommended range. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 13-APR-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 72 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Age: 0.49
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Brain neoplasm, Herpes zoster disseminated, Immunodeficiency, Immunology test, Rash papular
Clinical narrative: This spontaneous report as received from a physician refers to a 9 year old female patient with residual pain hypopituitary and sulfa and vancomycin allergies. The patient did not have recent Varicella Zoster Virus (VZV) exposure to chickenpox or shingles. On 27-APR-2006, at 5 months age, the patient was vaccinated with a first dose of VARIVAX (Merck) (route, lot # and expiration date were not provided). Then on 22-JUN-2011, at five years old, the patient was vaccinated with a second dose of VARIVAX (Merck) (also reported as PROQUAD) batch reported as "0141Z". Concomitant therapies included SYNTHROID, CORTEF, somatropin (manufacturer unknown) and desmopressin acetate (DDAVP). On an unknown date in 2011, the patient had a remote history of brain cancer/tumor resected in 2011 and his last chemotherapy was in 2012. On 01-JUL-2015, the patient experienced herpes zoster referred as disseminated shingles, rash type "vesicles and papules", she was also afebrile. The patient presented less than 100 lesions distributed over the trunk, extremities, hands, palms and soles. On 04-JUL-2015, the immunocompromised child was hospitalized and a sample from a vesicle/lesion was collected. Direct Fluorescent Antibody (DFA) was done from lesion on "7.2" that was positive for varicella zoster virus (VZV) dermatome diffuse and discarded. The rash did not occur at the site of injection post-vaccination. It was also stated that the patient did not experience pneumonitis or hepatitis. The patient was intravenously treated with acyclovir (manufacturer unknown). On an unknown date in July 2015, the outcome of herpes zoster was recovered and the brain cancer was considered as recovered in 2012. The physician stated that the child may be discharged from the hospital on 06-JUL-2015 but it was unknown whether she was discharged or not. Upon internal review, the brain cancer/tumor was considered as other important medical event. Additional information has been requested.
Age: 0.49
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Skin lesion, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a physician refers to a 9 year old female patient with residual pain hypopituitary and sulfa and vancomycin allergies. The patient did not have recent Varicella Zoster Virus (VZV) exposure to chickenpox or shingles. On 27-APR-2006, at 5 months age, the patient was vaccinated with a first dose of VARIVAX (Merck) (route, lot # and expiration date were not provided). Then on 22-JUN-2011, at five years old, the patient was vaccinated with a second dose of VARIVAX (Merck) (also reported as PROQUAD) batch reported as "0141Z". Concomitant therapies included SYNTHROID, CORTEF, somatropin (manufacturer unknown) and desmopressin acetate (DDAVP). On an unknown date in 2011, the patient had a remote history of brain cancer/tumor resected in 2011 and his last chemotherapy was in 2012. On 01-JUL-2015, the patient experienced herpes zoster referred as disseminated shingles, rash type "vesicles and papules", she was also afebrile. The patient presented less than 100 lesions distributed over the trunk, extremities, hands, palms and soles. On 04-JUL-2015, the immunocompromised child was hospitalized and a sample from a vesicle/lesion was collected. Direct Fluorescent Antibody (DFA) was done from lesion on "7.2" that was positive for varicella zoster virus (VZV) dermatome diffuse and discarded. The rash did not occur at the site of injection post-vaccination. It was also stated that the patient did not experience pneumonitis or hepatitis. The patient was intravenously treated with acyclovir (manufacturer unknown). On an unknown date in July 2015, the outcome of herpes zoster was recovered and the brain cancer was considered as recovered in 2012. The physician stated that the child may be discharged from the hospital on 06-JUL-2015 but it was unknown whether she was discharged or not. Upon internal review, the brain cancer/tumor was considered as other important medical event. Additional information has been requested.
Age: 0.49
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Brain neoplasm, Herpes zoster, Immunology test abnormal, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 9 year old female patient with residual pain hypopituitary and sulfa and vancomycin allergies. The patient did not have recent Varicella Zoster Virus (VZV) exposure to chickenpox or shingles. On 27-APR-2006, at 5 months age, the patient was vaccinated with a first dose of VARIVAX (Merck) (route, lot # and expiration date were not provided). Then on 22-JUN-2011, at five years old, the patient was vaccinated with a second dose of VARIVAX (Merck) (also reported as PROQUAD) batch reported as "0141Z". Concomitant therapies included SYNTHROID, CORTEF, somatropin (manufacturer unknown) and desmopressin acetate (DDAVP). On an unknown date in 2011, the patient had a remote history of brain cancer/tumor resected in 2011 and his last chemotherapy was in 2012. On 01-JUL-2015, the patient experienced herpes zoster referred as disseminated shingles, rash type "vesicles and papules", she was also afebrile. The patient presented less than 100 lesions distributed over the trunk, extremities, hands, palms and soles. On 04-JUL-2015, the immunocompromised child was hospitalized and a sample from a vesicle/lesion was collected. Direct Fluorescent Antibody (DFA) was done from lesion on "7.2" that was positive for varicella zoster virus (VZV) dermatome diffuse and discarded. The rash did not occur at the site of injection post-vaccination. It was also stated that the patient did not experience pneumonitis or hepatitis. The patient was intravenously treated with acyclovir (manufacturer unknown). On an unknown date in July 2015, the outcome of herpes zoster was recovered and the brain cancer was considered as recovered in 2012. The physician stated that the child may be discharged from the hospital on 06-JUL-2015 but it was unknown whether she was discharged or not. Upon internal review, the brain cancer/tumor was considered as other important medical event. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea & vomiting approx. 5 minutes after receiving vaccinations. Not ill before or after this instance.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Fatigue, Malaise, Migraine, Rash generalised, Rash papular
Clinical narrative: Fatigue, malaise, migraines, and generalized papular rash involving chest, back, shoulders, and groin.
Age: 32.0
Sex: F
Vaccine: SMALL
Symptoms: Blister, Headache
Clinical narrative: BLISTERS INVOLVING HANDS, ELBOWS BILATERAL, AND HAIRLINE, W/HEADACHES.
Age: 39.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: 2 red, circular spots discovered 7/11/15 by patient's mother.  Spots located adjacent to subcutaneous site of injection on the left upper arm.  One circular spot is approx. 3" diameter; the other is approx. 5" diameter.  Spots appear to be enlarging.  Advised a doctor/ER visit stat.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site rash, Myalgia, Pruritus, Pyrexia
Clinical narrative: Developed slight fever 99.6 and the following joints were achy for 2 days: left ankle, left and right knees, left hip and right shoulder. Also muscle pain left side of abdomen and back. Pain was managed by Advil and symptoms disappeared on the second day. Slight body itch and very small bumps at injection site.
Age: 1.59
Sex: M
Vaccine: FLUX, MMR
Symptoms: Aphasia, Screaming
Clinical narrative: Steep decline in speech. Within several months increase in screaming fits that he can't be calmed from easily. Starting speech therapy.
Age: 0.31
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Crying, Dyskinesia, Electroencephalogram normal, Myoclonus, Pain
Clinical narrative: Jerking or arm and neck/head during sleep (while falling asleep and during REM sleep). Accompanied by episodes of inconsolable painful crying during sleep and possible night terrors. Movements lasted for a few months. EEG was given to check for seizure activity, results were negative. Neurologist diagnosed myoclonus caused by vaccines. Pediatrician and Neurologist agreed that the movements were caused by the DTaP vaccine.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Confusional state, Decreased appetite, Dizziness, Injection site swelling, Nausea
Clinical narrative: Severe swelling at injection arm swollen to 1.5 -2 times normal size  entire triceps area very sore and hot, nausea, dizziness, Fever 99-100 degrees, mental confusion, very sleepy, loss of appetite, 07/11/2015 triceps still very sore...some nausea and dizzeness remaining.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Skin warm, Somnolence
Clinical narrative: Severe swelling at injection arm swollen to 1.5 -2 times normal size  entire triceps area very sore and hot, nausea, dizziness, Fever 99-100 degrees, mental confusion, very sleepy, loss of appetite, 07/11/2015 triceps still very sore...some nausea and dizzeness remaining.
Age: 32.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Unevaluable event
Clinical narrative: Getting invalid error entry.
Age: 32.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Activities of daily living impaired, Albumin CSF abnormal, Anaphylactic reaction, Bed rest, Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Getting invalid error entry.
Age: 32.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Demyelination, Dystonia, Gait disturbance, Grip strength decreased, Guillain-Barre syndrome
Clinical narrative: Getting invalid error entry.
Age: 32.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Hyperaesthesia, Hypoaesthesia, Hyporeflexia, Immunoglobulin therapy, Injected limb mobility decreased
Clinical narrative: Getting invalid error entry.
Age: 32.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Injury, Insomnia, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Getting invalid error entry.
Age: 32.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Nerve conduction studies abnormal, Pain, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Getting invalid error entry.
Age: 32.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Rash, Sensory disturbance, Sensory loss, Serology test, Skin exfoliation
Clinical narrative: Getting invalid error entry.
Age: 32.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Tremor, Wheelchair user
Clinical narrative: Getting invalid error entry.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Headache, Nasal congestion, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Started with a mild sore throat. By evening, sore throat had worsened and was accompanied by headache and stuffy nose. By the next morning, sore throat was still present, along with alternately stuffy and runny nose, mild dry cough, post nasal drip, and tender sinus. Most symptoms are occurring on the side of the body where the vaccine was administered (left arm, left side of throat, left sinus, left nasal passage).
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Sinus headache, Upper-airway cough syndrome
Clinical narrative: Started with a mild sore throat. By evening, sore throat had worsened and was accompanied by headache and stuffy nose. By the next morning, sore throat was still present, along with alternately stuffy and runny nose, mild dry cough, post nasal drip, and tender sinus. Most symptoms are occurring on the side of the body where the vaccine was administered (left arm, left side of throat, left sinus, left nasal passage).
Age: 29.0
Sex: M
Vaccine: HEPAB, IPV, MEN, MMR, PPV, VARCEL
Symptoms: Arthralgia, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Joint aches, body aches, head ache, fever. Extreme dizziness and blurry vision, fainting.
Age: 29.0
Sex: M
Vaccine: HEPAB, IPV, MEN, MMR, PPV, VARCEL
Symptoms: Syncope, Vision blurred
Clinical narrative: Joint aches, body aches, head ache, fever. Extreme dizziness and blurry vision, fainting.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal pain, Aggression, Arthralgia, Blood test, Computerised tomogram
Clinical narrative: These symptoms started at various times and have gotten progressively worse...seizures (especially when tired or stressed), migraine headaches, IBS, tingling in hands, joint aches, endometriosis, tiredness, temper outbursts, severe menstual cramps, excessive menstrual bleeding, 2 exploratory surgeries to determine cause of abdominal pain, sensitivity to light and temperature differences.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Dysmenorrhoea, Endometriosis, Exploratory operation, Fatigue, Irritable bowel syndrome
Clinical narrative: These symptoms started at various times and have gotten progressively worse...seizures (especially when tired or stressed), migraine headaches, IBS, tingling in hands, joint aches, endometriosis, tiredness, temper outbursts, severe menstual cramps, excessive menstrual bleeding, 2 exploratory surgeries to determine cause of abdominal pain, sensitivity to light and temperature differences.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Menorrhagia, Migraine, Nuclear magnetic resonance imaging, Paraesthesia, Photophobia
Clinical narrative: These symptoms started at various times and have gotten progressively worse...seizures (especially when tired or stressed), migraine headaches, IBS, tingling in hands, joint aches, endometriosis, tiredness, temper outbursts, severe menstual cramps, excessive menstrual bleeding, 2 exploratory surgeries to determine cause of abdominal pain, sensitivity to light and temperature differences.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Seizure, Temperature intolerance
Clinical narrative: These symptoms started at various times and have gotten progressively worse...seizures (especially when tired or stressed), migraine headaches, IBS, tingling in hands, joint aches, endometriosis, tiredness, temper outbursts, severe menstual cramps, excessive menstrual bleeding, 2 exploratory surgeries to determine cause of abdominal pain, sensitivity to light and temperature differences.
Age: 4.0
Sex: M
Vaccine: DPP, MMR, VARCEL
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Vomiting, Diarrhea, Fever, Lethargy, Pain, Redness, Swelling at injection site.
Age: 4.0
Sex: M
Vaccine: DPP, MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting, Diarrhea, Fever, Lethargy, Pain, Redness, Swelling at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and tenderness at injection site.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site reaction, Pain, Pyrexia, Rash erythematous
Clinical narrative: Patient said on 7/11/15 that she had a flat red rash around the site of immunization injection the diameter of a baseball. She also felt achy with joints hurting a feverish. After taking otc Benadryl on 7/11/15 she felt better and the rash was much smaller.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Hives/Rash.
Age: 22.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Wrong drug administered
Clinical narrative: Patient was supposed to recieve Hep B vaccine. Medic grabbed Hep A instead of grabbing Hep B and administered the wrong vaccine to patient. When medic was documenting after administration he noticed he had given the wrong vaccine.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, chills, joint pain, fever up to 101.4C.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Hypoaesthesia, Lacrimation increased, VIIth nerve paralysis
Clinical narrative: Numbness on left side of face. Headache, watery eyes, dropping left side of mouth.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Chronic spontaneous urticaria, Laboratory test normal, Reaction to food additive, Swelling, Urticaria
Clinical narrative: Patient broke out in hives and swelling all over her body.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practice nurse referring to an unspecified patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of MMR II (dose, frequency, route and lot number not provided). No adverse events were reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain, Skin induration, Skin swelling
Clinical narrative: Stated pt had pain > 7 days after vaccine given no visible injury can be observed on skin surface but it is swollen a bit and felt hard to the touch. Pt said movement to that arm (left) was irritated.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a 51 year old female patient. Pertinent medical history or drug reactions/allergies were unknown. On 21-JUN-2015, the patient was vaccinated with an expired dose of MMR II (Lot number: # J006953 with expiration date: 07-JUN-2015, dose, route were unspecified). No adverse effects were reported. Additional information has been requested.
Age: 0.05
Sex: M
Vaccine: HEP
Symptoms: Erythema multiforme, Respiratory syncytial virus infection
Clinical narrative: Information has been received from a physician referring to a 2 to 3 weeks old male patient. The patient had no medical history or drug reactions/allergies. On an unspecified date in 1999, the patient was vaccinated with his first dose of RECOMBIVAX HB (dose, frequency and lot# were not reported). Then, on an unspecified date in "February of 1999", he received his second dose of RECOMBIVAX HB (dose, frequency and lot# were not reported). There was no concomitant medication. Then, on an unspecified date "3 to 5 days later", the patient developed erythema multiforme. Then, on an unspecified date "a couple weeks later," the patient recovered. The patient also developed respiratory syncytial virus on an unspecified date "at 2 to 3 weeks of age". The patient recovered on an unspecified date. The patient sought medical attention via seeing a physician. No lab diagnostics studies were performed. Causality was not reported. Action taken with RECOMBIVAX HB was not applicable. Additional information has been requested.