chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On unspecified dates, patients were vaccinated with improperly-stored doses of GARDASIL 9 injection, (strength and dose were not reported) (lot # M017983, expiration date 30-MAY-2018) for prophylaxis. According to the reporter, GARDASIL 9 doses were exposed to the following temperature excursions: 51 hours between 32 degrees Fahrenheit (F) and 35F, and for 14 hours and 15 minutes between 47F and 77F (60F). No adverse effects were reported. A digital data logger was involved. This is one of several reports from the same reporter. Additional information is not expected as the reporter refused additional contact.; Sender's Comments: US-009507513-1705USA000386: US-009507513-1705USA000339:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: 4/6, Father reported rash from top of hand up back and front of arm. BENADRYL x 3 days until resolved. 4/7, Spoke with Mother. Mom said applied BENADRYL an cortisone cream the evening rash started. 4.7, Mom advised to do a nurse visit in future if SXs again after inj.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count normal, Lymphadenopathy
Clinical narrative: Localized enlarged lymph nodes.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: The next day after the shot my arm was sore. The pain got worse over the next couple of months so I went to a different doctor from there on.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site urticaria, Rash erythematous
Clinical narrative: MMRV administered. Rash flat, confluent, red, extended from later side of left eye, to mouth spread to ear, back of neck, hairline with extension to right side of face. MMRV site red, welts, at site.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Emotional distress, Injection site erythema, Injection site mass, Injection site rash, Injection site swelling
Clinical narrative: Parent called, 4 1/2 hrs post vaccination, (L) thigh (PENTACEL site) swelled, rash below the knee, thigh with lump and redness, inconsolable x 2 hrs. TYLENOL given. Pt sent to ER, thigh swelling in ER, worse than initially noted. ER gave BENADRYL, monitored x 2hrs. Pt improved with no further S/S. Referred to allergist.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left Deltoid redness and warm to touch. Monitor. Use topic antibiotic and monitor.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: Left Deltoid redness and warm to touch. Monitor. Use topic antibiotic and monitor.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal distension, Chest discomfort, Heart rate increased, Insomnia, Neck pain
Clinical narrative: Extremely swollen arm, too painful to sleep, pain in my neck and chest seemed tight, rapid heartbeat, stomach felt bloated, couldn't think clearly, this went on for 24 hrs. All symptoms finally subsided 48 hrs after vaccination. No fever at all. I was told my color was not good.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pallor, Peripheral swelling, Thinking abnormal
Clinical narrative: Extremely swollen arm, too painful to sleep, pain in my neck and chest seemed tight, rapid heartbeat, stomach felt bloated, couldn't think clearly, this went on for 24 hrs. All symptoms finally subsided 48 hrs after vaccination. No fever at all. I was told my color was not good.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ, VARCEL
Symptoms: Rash, Syncope
Clinical narrative: Friday a.m. a rash started on the thigh and progressed down both legs.  Pt. was given 4 dispersed doses of Benadryl, 25 mg. P.O. and then on Saturday taken to an Urgent Care Center where she was administered steroids.
Age: 65.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and warmth around site of injection.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No reaction. child received a dose of Hep A too soon.
Age: 36.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Hypotension, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Was not aware that vaccine contained latex. Lightheartedness, Hives, Right Arm Swelling, Fever, Nausea, Hypo tension, Tachycardia Treated with IV Zoysin, Benadryl, Pepcid, IV Fluids, ER and Hospital Observation for 20 hours.
Age: 36.0
Sex: F
Vaccine: MENB
Symptoms: Tachycardia, Urticaria
Clinical narrative: Was not aware that vaccine contained latex. Lightheartedness, Hives, Right Arm Swelling, Fever, Nausea, Hypo tension, Tachycardia Treated with IV Zoysin, Benadryl, Pepcid, IV Fluids, ER and Hospital Observation for 20 hours.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: On 28 April he received Anthrax vaccine (dose #10) in his left deltoid and approximately 24 hours he noted redness, swelling, and warmth surrounding the vaccination site which extended from his shoulder over his bicep. He denies fever/chills, fatigue, malaise, arthralgias/myalgias, painful/swollen joints, generalized rash, pulmonary symptoms, GI symptoms, and neurologic symptoms. He feels the redness is improving. He says no reaction to prior vaccination.
Age: 0.75
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given a pediatric dose of Hepatitis A prior to age 12 months. Mom was notified.  Will repeat dose at 15 months with booster 6 months after.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Immunization site is red and hot to the touch. It is 3.5 x 3.5 area of redness and swelling. Looks like a bullseye. Pt. states it is painful. Grandmother said it started the day of the vaccination. As of today it is still red and hot.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: This spontaneous report was received from a purchaser and refers to a 65-year-old female patient with an allergy to penicillin. The patient did not have pertinent medical history and concomitant therapies. On 06-APR-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot number reported as N005096, expiration date: 22-OCT-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided) for prophylaxis (reported as vaccination). Subsequently, on 07-APR-2017, the patient sought medical attention through a call she made to a facility in which she mentioned that she was experiencing hives, redness, and swelling at the injection site and it was "warm to the touch", however, no treatment was provided to the patient. The patient did not undergo any laboratory test or diagnostic procedure. At the reporting time, it was unknown whether the patient recovered or not from the adverse events. The causal relationship between the therapy with PNEUMOVAX 23 and the adverse events was not provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that an improper dose of PROQUAD lot number: M034692, expiration date: 24-JAN-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided), was administered for prophylaxis. The vaccine was reconstituted with a sterile diluent lot number: M015992, expiration date: 26-NOV-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided). The vaccine was exposed to a temperature of 15.8 Fahrenheit (F) for 2 hours and 25 minutes. The call was not because of a data logger issue and there was no previous temperature of excursion. No adverse effects reported. There was no product quality complaint involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000419:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 60 year-old female patient. There were no concurrent conditions, medical history or concomitant medications reported. The patient presented a codeine drug reaction/allergy. On 21-APR-2017, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX (dose, frequency, lot # and expiration date were not reported) for prophylaxis (reported as "vaccination"). On 22-APR-2017, a rash appeared on the patient's injection site; this rash was described as warm, red and slightly raised. The pharmacist was unaware of any treatment patient received before returning to pharmacy on 24-APR-2017. It was reported that packet was offered and the health care professional (HCP) was adamant about not receiving, so packet was not faxed. At the time of the report, she had not recovered from the adverse event. The causality between the adverse event and ZOSTAVAX was unknown.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 24-APR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 (dose, frequency and route were not reported) lot # L017265 with expiration date of 10-FEB-2017, for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a female patient of an unknown age, referring to herself. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was intravenously vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. Subsequently, after receiving the mentioned vaccine, she experienced a red spot on her arm near the injection site. At the time of the report, the outcome of the adverse event was unknown. The causality between the adverse event and ZOSTAVAX was unknown. Additional information is not expected, as no consent to contact the reporter was granted.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection vials (dose, frequency and route were not reported) lot # M043424 with expiration date of 06-JUN-2018, for prophylaxis. The temperature of the PNEUMOVAX 23 was between 0 °C and 1 °C (1 °C) for a time frame of 30 minutes; below -1 °C (-1°C) for a time frame of 30 minutes.. No previous temperature excursion occurred and no data logger was involved. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA000411: US-009507513-1705USA000410.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 28-APR-2017, the patient was vaccinated with an expired dose of PROQUAD, lot number L040411 with expiration date 13-APR-2017; the vaccine was reconstituted with sterile diluent, lot number reported as L015433 with expiration date 24-JAN-2018, (dose, route and anatomical location were not reported for the above products described) for prophylaxis. 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, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored dose of PEDVAXHIB (dose, frequency and route were not reported) lot # M025193 with expiration date of 21-MAR-2019 and lot # M036612 with expiration date of 19-MAY-2019, for prophylaxis. The temperature of the PEDVAXHIB was between 0 °C and 1 °C (1 °C) for a time frame of 30 minutes; below -1 °C (-1°C) for a time frame of 30 minutes. No previous temperature excursion occurred and no data logger was involved. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA015181: US-009507513-1705USA000411.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored dose of ROTATEQ (dose, frequency and route were not reported) lot # reported as M03872 with expiration date of 25-APR-2018, for prophylaxis. The temperature of the ROTATEQ was between 0 °C and 1 °C (1 °C) for a time frame of 30 minutes; below -1 °C (-1°C) for a time frame of 30 minutes.. No previous temperature excursion occurred and no data logger was involved. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA015181: US-009507513-1705USA000410.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that an improper dose of PROQUAD lot number: M034692, expiration date: 24-JAN-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided), was administered for prophylaxis. The vaccine was reconstituted with a sterile diluent lot number: M015992, expiration date: 26-NOV-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided). The vaccine was exposed to a temperature of 15.8 Fahrenheit (F) for 2 hours and 25 minutes. The call was not because of a data logger issue and there was no previous temperature of excursion. No adverse effects reported. There was no product quality complaint involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004548:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody positive, Biopsy artery abnormal, Blood alkaline phosphatase increased, C-reactive protein increased, Double stranded DNA antibody positive
Clinical narrative: Pt. developed progressive myalgias after ZOSTAVAX vaccine. Rheumatology consulted and diagnosed polymyalgia rheumatica and referred to vascular surgery and had bilateral temporal artery biopsies for Giant Cell Arteritis. Pt. treated with prednisone started 5/19/15 and ending October 2016.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Pt. developed progressive myalgias after ZOSTAVAX vaccine. Rheumatology consulted and diagnosed polymyalgia rheumatica and referred to vascular surgery and had bilateral temporal artery biopsies for Giant Cell Arteritis. Pt. treated with prednisone started 5/19/15 and ending October 2016.
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction, Rash erythematous, Skin discolouration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of erythematous rash in a 1-day-old female patient who received ENGERIX B pediatric. On 11th April 2017, the patient received the 1st dose of ENGERIX B pediatric (intramuscular). On 11th April 2017, several hours after receiving ENGERIX B pediatric, the patient experienced erythematous rash and mottled skin. ENGERIX B pediatric was continued with no change. On 12th April 2017, the outcome of the erythematous rash and mottled skin were recovering/resolving. It was unknown if the reporter considered the erythematous rash and mottled skin to be related to ENGERIX B pediatric. Additional details were provided as follows: The patient received a dose of ENGERIX B pediatric on right thigh. The patient developed a red mottled rash from hip to knee on the vaccinated leg, following the birth dose of ENGERIX B pediatric. The rash spread to the foot on the affected side. On 12th April 2017 while discharge, it was noted that red patched had cleared on the hip and buttocks and it was less extensive. The health care professional was unable to provide lot number or expiration date, as the report was made from the doctor's office and the vaccine was administered in a hospital.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Skin warm
Clinical narrative: Severe warm and painful rash.
Age: 16.0
Sex: F
Vaccine: HPV9, MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: HPV, MMR and varicella vaccines given to pregnant patient.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Dysstasia, Tremor
Clinical narrative: Per mother, body shakes on 4/20/17. Eyes did not roll, no fever, no temperature, no other symptoms. Child could not stand but could answer questions. Episode lasted 5-6 minutes. Happened again 4/28/17.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: RASH AT INJECTION SITE.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh red and swollen.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Post vaccination autoinoculation
Clinical narrative: Cross auto inoculation to left deltoid area.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Rash generalised, Urticaria
Clinical narrative: Urticarial type rash over entire body.
Age: 16.0
Sex: M
Vaccine: TYP, YF
Symptoms: Headache, Pyrexia
Clinical narrative: Patient developed fever up to 102.6 with headache.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Patient has small rash on stomach and around injection site.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient called on the morning of May 1st, 2017 complaining of "red, raised and swollen about 2 inches below the injection site, and inside the bicep". The vaccine was given on April 22, 2017. Patient was advised to use cold compress and take ibuprofen and we will follow up with patient.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Blister, Dizziness, Ear discomfort, Ear pain, Eye pain
Clinical narrative: Small blisters starting on back of neck, down spine and around trunk. Fever. Ear pain with popping. Sharp pain over eye and nose bridge. Dizziness.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis A antibody positive, Pyrexia, Rhinalgia
Clinical narrative: Small blisters starting on back of neck, down spine and around trunk. Fever. Ear pain with popping. Sharp pain over eye and nose bridge. Dizziness.
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Pruritus, Urticaria
Clinical narrative: Developed itchy welts on hands, trunk and bottom of her feet.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, PNC13, VARCEL
Symptoms: Abnormal behaviour, Aggression, Anger, Crying, Depressed mood
Clinical narrative: Same week behavioral/emotional changes began. Angry, combative, physical aggressiveness, crying. Very moody, sad, depressed. Other symptoms occurred - at 6 years began to develop body hair/odor, in 3-4 months after vax went from size 6 to 3-5 in teenagers, grew tall, there was weight gain. Bed wetting daily after vaccine and now continues to 2-3 times a week. Was potty trained at about 2-3 years normally. Took her to doctor due to weight gain and encouraged to remove dairy. Remove dairy but did not impact changes. She is about 10 now and she is probably going to have her period by the summer. Siblings did not present these puberty-like symptoms until 12. Schedule for next dose of vaxs at 11.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, PNC13, VARCEL
Symptoms: Emotional disorder, Enuresis, Hypertrichosis, Mood altered, Precocious puberty
Clinical narrative: Same week behavioral/emotional changes began. Angry, combative, physical aggressiveness, crying. Very moody, sad, depressed. Other symptoms occurred - at 6 years began to develop body hair/odor, in 3-4 months after vax went from size 6 to 3-5 in teenagers, grew tall, there was weight gain. Bed wetting daily after vaccine and now continues to 2-3 times a week. Was potty trained at about 2-3 years normally. Took her to doctor due to weight gain and encouraged to remove dairy. Remove dairy but did not impact changes. She is about 10 now and she is probably going to have her period by the summer. Siblings did not present these puberty-like symptoms until 12. Schedule for next dose of vaxs at 11.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, PNC13, VARCEL
Symptoms: Skin odour abnormal, Weight increased
Clinical narrative: Same week behavioral/emotional changes began. Angry, combative, physical aggressiveness, crying. Very moody, sad, depressed. Other symptoms occurred - at 6 years began to develop body hair/odor, in 3-4 months after vax went from size 6 to 3-5 in teenagers, grew tall, there was weight gain. Bed wetting daily after vaccine and now continues to 2-3 times a week. Was potty trained at about 2-3 years normally. Took her to doctor due to weight gain and encouraged to remove dairy. Remove dairy but did not impact changes. She is about 10 now and she is probably going to have her period by the summer. Siblings did not present these puberty-like symptoms until 12. Schedule for next dose of vaxs at 11.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Skin warm
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of skin warmth in a 5-year-old female patient who received KINRIX (batch number G35ZK, expiry date 2nd December 2017). Concomitant products included PROQUAD. On 18th April 2017 14:30, the patient received the 1st dose of KINRIX (intramuscular) .5 ml. On 20th April 2017, 2 days after receiving KINRIX, the patient experienced skin warm and injection site swelling. On an unknown date, the outcome of the skin warm and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the skin warm and injection site swelling to be related to KINRIX. Additional details were reported as follows: The patient received a dose of KINRIX on left deltoid. On 19th April 2017, the patient received 1st does of PROQUAD (batch number: M032497, expiry date: 2nd January 2018) on left arm. The health care provider reported that the patient arm was warm to the touch with mild swelling of the skin.
Age: 5.0
Sex: F
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Aggression, Anger, Crying, Erythema
Clinical narrative: Right away right arm, right away, was red, sore, hurt for about 3 days. Got worse and went away by 4/26. The day she got it behavioral changes began, angry, crying, combative, not constantly aggressive but frustrated. Behavior not regular for her. Went back to normal within 1 week. Symptoms remind parent of problems with sibling that have prolonged. Will schedule an appointment with doctor for follow-up.
Age: 5.0
Sex: F
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Frustration tolerance decreased, Pain
Clinical narrative: Right away right arm, right away, was red, sore, hurt for about 3 days. Got worse and went away by 4/26. The day she got it behavioral changes began, angry, crying, combative, not constantly aggressive but frustrated. Behavior not regular for her. Went back to normal within 1 week. Symptoms remind parent of problems with sibling that have prolonged. Will schedule an appointment with doctor for follow-up.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This case was reported by a other health professional and described the occurrence of erythema in a 11-year-old female patient who received MENVEO (batch number A16093, expiry date March 2018). On 6th February 2017, the patient received MENVEO (intramuscular). On an unknown date, less than a year after receiving MENVEO, the patient experienced erythema and swelling arm. On an unknown date, the outcome of the erythema and swelling arm were recovered/resolved. It was unknown if the reporter considered the erythema and swelling arm to be related to MENVEO. Additional details were reported as follows: The patient experienced redness in arm and swelling (9 x 6 cm) raised area, lasting for 2 days.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Drug administered at inappropriate site, Impaired work ability, Injected limb mobility decreased, Pain in extremity, Screaming
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 34-year-old female patient who received RABAVERT NVS. On 12th April 2017, the patient received the 3rd dose of RABAVERT 1 ml. On 12th April 2017, unknown after receiving RABAVERT, the patient experienced vaccine administered at inappropriate site and wrong injection technique. In April 2017, the patient experienced pain in arm. The patient was treated with ADVIL. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the vaccine administered at inappropriate site and wrong injection technique were unknown. It was unknown if the reporter considered the pain in arm to be related to RABAVERT. Additional details were reported as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient received the a dose of the RABAVERT vaccine as a prophylaxis treatment for a bat that was found in their home and the nurse that administered the vaccine was shaking violently and the injection was administered in her bursa or joint muscle rather than her deltoid muscle, which led to vaccine administered at inappropriate site and wrong injection technique. The patient experienced arm pain for three days and she could not move her arm which was improving at the time of reporting. The patient was screaming all night due to the pain and her father who was a physician, prescribed prescription ADVIL to take around the clock and advised to stay home from work. The hospital staff confirmed that the nurse that administered the vaccine had a problem but they would not confirm what the issue was with her hand shaking. The patient's healthcare provider recommended a four dose series as a prophylaxis treatment for RABAVERT.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site vesicles, Peripheral swelling, Skin disorder
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of redness in a 4-year-old female patient who received KINRIX (batch number A73C4, expiry date 29th March 2019). Concomitant products included PROQUAD. On 19th April 2017, the patient received the 1st dose of KINRIX (intramuscular) .5 ml. In April 2017, less than a week after receiving KINRIX, the patient experienced swelling arm, injection site vesicles and skin breakdown. On 20th April 2017, the patient experienced redness. On an unknown date, the outcome of the redness, swelling arm, injection site vesicles and skin breakdown were not recovered/not resolved. It was unknown if the reporter considered the redness, swelling arm, injection site vesicles and skin breakdown to be related to KINRIX. Additional details were provided as follows: It was reported that the patient's birth weight was 3.820g. At 14:05 hours, the patient received a dose of KINRIX in left deltoid. On 19th April 2017, the patient received a dose of PROQUAD (batch number: M032497, expiry date: 2nd January 2018) on left arm. The healthcare provider reported to the sales representative that the patient developed redness in the left arm 1 day after the vaccine was administered. It was also reported that the patient had redness and swelling of the whole arm most around injection side. Multiple vesicles developed around injection site and skin breakdown occurred about a dime size.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Pain, Pyrexia
Clinical narrative: Patient stated all joints achy 1 day after the injection. Unknown fever- Felt achy "for awhile" arm still hurts at injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Local swelling, Pyrexia
Clinical narrative: Patient had an allergic reaction to the ZOSTAVAX. Pt. developed a red oval area 3x4 long. It was also swollen. Pt. complained of Hx of fever which was relieved by TYLENOL. Will follow up w/pt. - to take BENADRYL for allergic reaction. Pt will also f/u w/Dr. I contacted Dr. in regards with no other concerns.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site urticaria, Urticaria
Clinical narrative: DTaP vaccination on 3/27/17. 3/29/17 mother called redness around injection site. 4/3/17 -mother called - child developed hives around injection site 5 days later and hives progressed to whole body. (verified by photo).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient came in to pharmacy on 4-30-17 w/redness and itching at the vaccination site. It presented the day after vaccination and has gotten larger in the past day.
Age: 10.0
Sex: M
Vaccine: HEP, HEPA, IPV, TDAP
Symptoms: Cellulitis, Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm is very sore, red and swollen. Hard and warm to the touch on 4/28/2017. Mom is giving paracetamol (like TYLENOL). Patient was stated on a oral antibiotic for a cellulitis type change (infection) on 4/28/2017 per Dr.
Age: 10.0
Sex: M
Vaccine: HEP, HEPA, IPV, TDAP
Symptoms: Skin warm
Clinical narrative: Left arm is very sore, red and swollen. Hard and warm to the touch on 4/28/2017. Mom is giving paracetamol (like TYLENOL). Patient was stated on a oral antibiotic for a cellulitis type change (infection) on 4/28/2017 per Dr.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Pain, Vaccination site swelling
Clinical narrative: Red, swollen and itchy arm where vaccine administered. Sore.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness with orange bump on left deltoid.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: Limited movement in left arm. Frequent aches.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site urticaria
Clinical narrative: A week after receiving infant DTaP patient developed hive around injection site that spread progressively outward in the upper arm. (verified from photo mother took).
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Urticaria, Vomiting
Clinical narrative: HIB 1 given today. Patient went home for a nap right after vaccine. When awoke - 1 hour later had hives. Vomited once. No other symptoms.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Crying, Irritability
Clinical narrative: Inconsolable crying x 2 days following 2nd DTaP. Irritability gradually resolved over course of 1 week. Prior to this vaccine, he was vocalizing a lot. Vocalizing stopped x 3 weeks. Now returned to normal.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Received KINRIX on right thigh during nurse visit on 4/28/17. Patient developed swelling, redness and itching near injection site. Erythema noted as 10 cm x 10.5 cm.
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Muscle twitching, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 595652) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 17 year old male patient. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and other medications were not reported. The patient's medical history included reactive airway disease. On 25-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L006547, via intramuscular route in the left arm for prophylaxis (dosage and expiry date unspecified). On 25-AUG-2015, the patient twitched and lost consciousness for a few seconds. It was thought to be a faint episode while patient was seated on exam table. The patient was monitored, made to drink water and a sucker. The patient was rested and discharged in good condition. The outcome of loss of consciousness, syncope and muscle twitching was reported as recovered. Causality for the events were not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dysphagia, Headache, Paraesthesia, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 597618) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 21-SEP-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L013429, dose 3, intramuscularly in the left arm for prophylaxis. On 21-SEP-2015, the patient experienced dysphagia, paraesthesia oral, pharyngeal oedema, paraesthesia and headache which required ER (Emergency room) visit. Patient was advised to call emergency by after hours triage and were not able to reach them at that point. The outcome of dysphagia, paraesthesia oral, pharyngeal oedema, paraesthesia and headache were unknown. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Electrocardiogram, Seizure, Syncope, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 603642) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. Information on patient's medical history and prior vaccinations were not reported. Patient's concurrent illnesses included slight cough. Other medications reported were Adderall, Prozac, Prilosec and hydroxyzine. On 09-OCT-2015 the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L016428, dose 2, intramuscularly in the left arm for prophylaxis. Patient had syncopal episode with convulsions. On 09-OCT-2015, the patient underwent electrocardiogram, seizure  and also experienced vomiting and syncope and  EKG showed possible conduction delay. Patient took prolonged time to recover and emesis occurred twice and hence, was taken to emergency department. The outcome of electrocardiogram, vomiting, syncope and seizure was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 603929) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 09-OCT-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L013429, dose 1, intramuscularly in the right arm for prophylaxis. Other suspect therapies included ADACEL (dose number: 1, vaccinated date: 09-OCT-2015, intramuscularly in the left arm, lot# U5241AA; dose and expiration date unknown), MENACTRA (dose number: 1, vaccinated date: 09-OCT-2015, intramuscularly in the right arm, lot# U5021AB; dose and expiration date unknown) and FLUZONE (dose number: 1, vaccinated date: 09-OCT-2015, intramuscularly in the left arm, lot# UI443AB; dose and expiration date unknown). On 14-OCT-2015, the patient developed "itchy bump" on right upper arm in evening. On 14-OCT-2015 ,the patient experienced injection site induration, injection site swelling and injection site pruritus. Patient was being treated by her mother with oral and topical BENADRYL. On 15-OCT-2015, at school area, there was enlargement of bump, over day and patient's mother brought her for check up at 2:30. Induration measured 5.5 x 7 at the injection site. The patient was prescribed for oral prednisolone for a 5 day course and OTC Hydrocortisone cream to the area. The outcome of injection site induration, injection site swelling and injection site pruritus were reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 609542) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 03-NOV-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L011846, dose 2, via unknown route in the left arm for prophylaxis. Approximately at 10:40 (reported as 1040), vaccine was administered to left deltoid. On 03-NOV-2015, the patient experienced dizziness, pallor and headache which required emergency visit. Patient became pale and grey in color. Patient was brought to room and made to lie down, heart rate measured 78, BP was 82/48 at 11:00. Patient began feeling dizzy at 11:30 and sat elevated with BP of 90/60. Patient ate crackers and drank ginger ale while in office. Patient walked up and down the hallway with no dizziness and returned to office 04-NOV-2015 with headache and dizziness. The outcome of dizziness, pallor and headache was reported as not recovered/not resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 610066) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 15 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 16-NOV-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L016428, via intramuscular route in the left arm for prophylaxis (dosage and expiry date unspecified). On 16-NOV-2015, the patient experienced dizziness, nausea and headache. The outcome of dizziness, nausea and headache were reported as recovered. Causality assessment for the events were not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Blood thyroid stimulating hormone, Chest discomfort, Electrocardiogram normal, Hypoaesthesia, Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 610088) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 18 year old male patient. The patient's medical history included anxiety, ADHD (attention deficit/hyperactivity disorder), hypothyroid, depression, dysthymia, ODD and obesity. The patient's other medication included Wellbutrin, Celexa, Adderrall XR, Synthroid and Ativan. Information on the patient's concurrent illnesses and prior vaccinations was not reported. On 04-NOV-2015 at 1.50 pm, the patient was vaccinated with the third dose of GARDASIL 9 lot # L019286, via intramuscular route in the left arm for prophylaxis (dosage and expiry date unspecified). On 04-NOV-2015, the patient complained to laboratory where he was given shot and felt numb. At 2.00 pm, the patient passed out in sub wait area. The patient was placed on oxygen, had nausea and vomited. Vital signs were stable, the patient had some chest tightness. EKG (electrocardiogram) was done and results were normal. The patient went home with his mother. The outcome of blood glucose, vomiting, nausea, loss of consciousness, injection site hypoaesthesia, electrocardiogram normal, chest discomfort and blood thyroid stimulating hormone was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Nausea, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 610088) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 18 year old male patient. The patient's medical history included anxiety, ADHD (attention deficit/hyperactivity disorder), hypothyroid, depression, dysthymia, ODD and obesity. The patient's other medication included Wellbutrin, Celexa, Adderrall XR, Synthroid and Ativan. Information on the patient's concurrent illnesses and prior vaccinations was not reported. On 04-NOV-2015 at 1.50 pm, the patient was vaccinated with the third dose of GARDASIL 9 lot # L019286, via intramuscular route in the left arm for prophylaxis (dosage and expiry date unspecified). On 04-NOV-2015, the patient complained to laboratory where he was given shot and felt numb. At 2.00 pm, the patient passed out in sub wait area. The patient was placed on oxygen, had nausea and vomited. Vital signs were stable, the patient had some chest tightness. EKG (electrocardiogram) was done and results were normal. The patient went home with his mother. The outcome of blood glucose, vomiting, nausea, loss of consciousness, injection site hypoaesthesia, electrocardiogram normal, chest discomfort and blood thyroid stimulating hormone was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 610426) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old male patient. The patient's medical history included allergy- clonidine (L WBC count). Patient's concurrent illnesses included 24 hrs later- s/s cellulitis. Patient's other medications included olanzapine, vyvanse, lamotrigine and docusate. Information on prior vaccinations was not reported. On 14-NOV-2015, patient was vaccinated with the first dose of GARDASIL 9 lot # L016428, via intramuscular route in the right arm for prophylaxis (dosage and expiry date unspecified). Other suspect therapies included FLUARIX batch # 9A995, dose 3, via intramuscular route in the left arm for prophylaxis (dosage and expiry date unspecified). On 15-NOV-2015, the patient had LD area redness, swelling, induration, tenderness and pain. The patient was treated with Keflex 500 mg, orally (PO), four times a day (QID) for 10 days for cellulitis. The outcome of the events cellulitis, injection site swelling, injection site pain, injection site induration and injection site erythema was reported as not recovered. Causality for the events were not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLUN4, HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 614531) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 14 year old male patient. The patient's pertinent medical history, other medications, current illnesses and prior vaccinations were not reported. On 10-DEC-2015, the patient was vaccinated with GARDASIL 9 dose number 1, lot # L013429, (dose and lot expiration date unknown) intramuscularly in the right arm for prophylaxis and VARIVAX (lot # L032395, dose number 1, subcutaneously in the left arm, dose and lot expiration date unknown) for prophylaxis. Other suspect therapies included FLUMIST (vaccinated date: 10-DEC-2015, lot # FK2037, intranasal, dose number, dose and lot expiration date were unknown), MENACTRA (vaccinated date: 10-DEC-2015, lot # U5178AA, intramuscularly in the left arm, dose number, dose and lot expiration date were unknown), BOOSTRIX (vaccinated date: 10-DEC-2015, lot # 9NA32, dose number 1, intramuscularly in the left arm, dose and lot expiration date unknown), HAVRIX (vaccinated date: 10-DEC-2015, lot # 294X9, dose number 1, intramuscularly in the left arm, dose and lot expiration date unknown)  On 10-DEC-2015, patient experienced an episode of syncope. The outcome of syncope was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.