chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: HEP, HIBV, IPV, PNC, TD
Symptoms: Injection site pain, Pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 12-Feb-2018. This case involves a 65-year-old female patient who was vaccinated with 0.5 ml single dose of IMOVAX POLIO (Batch number: N1G5IIM, expiry date and dose series was not reported) intramuscularly in left deltoid muscle on 01-Feb-2018. The patient also received a dose of ACTHIB, PREVNAR, ENGERIX-B and TENIVAC (Batch number, expiry date, dose in series and route of administration were not reported) in different thighs and other deltoid on 01-Feb-2018. The patient had history of cancer but had no known allergy. Concomitant medication was not reported. On 11-Feb-2018, ten days following the vaccination, the patient experienced arm pain from elbow to collarbone, with pain moving arm. It was also reported that patient was about to see physician for follow up. Relevant lab tests and corrective treatment was not reported. Outcome of the event was not recovered. List of documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Choking, Feeling abnormal, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Patient developed severe pain in left arm where vaccine administered with swelling. Complained of problems sleeping, choked x 1 and (L) leg felt "weird". Started the day of vaccine. Improving at this time.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Bruxism, Chills, Gait disturbance, Pain in extremity, Tremor
Clinical narrative: Got the shot on 2/8/18 at about 5:00 about 7/8:00 I started shaking like I was chilled but I was not cold. Through the night it got worse. I shook so bad my teeth were clinched. I opened them with my fingers. The shivering slowed down in the morning. It shivered all the day and was worn out. (When I got up at night I could hardly walk). My arm hurt for two days.
Age: 4.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Unnecessary additional dose of Hib and PCV 13 given. No adverse reaction noted by client.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Neutrophil count decreased, Petechiae, Platelet count decreased, White blood cell count decreased
Clinical narrative: PETECHIAE THEN PLATELET COUNT DROPPED TO 9,000 and  WHITE COUNT 1,400; ANC 320.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Headache, Injection site erythema
Clinical narrative: Large, red area at injection site appeared 2 weeks after vaccine. Patient reports headaches x 3 days, few small blisters noted on back of neck and under right arm.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient returned to pharmacy reporting arm is still painful to the point that she cannot use for extended period of time.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Erythema multiforme, Generalised erythema, Otitis media, Rash, Tympanic membrane disorder
Clinical narrative: 02/02/2018- Was prescribed Amoxicillin for 10 days. 02/20/2018- Patient started with a 1 cm circular spot rash on her torso. 02/21/2018- Diffuse redness covering all surfaces including skin surrounding both eyes (swollen) as well as covering spares palms and soles. Tympanic membrane appeared dull, bilaterally indicative of healing otitis media. Diagnosis: Erythema Multiforme. Treatment: OTC Children's BENADRYL, 0.5 tsp q 6-8 hours and follow up today 02/23/2018.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Received KINRIX and Flu vaccine to right thigh on 2/20/18. Parent states patient had tactile fever after vaccine but none noted the day of office visit. MD notes indicate "13x10 cm oval erythematous raised warm on dorsal aspect of right thigh, non-tender. Per Dr. when evaluated 2/22/18.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Vaccination complication
Clinical narrative: Received KINRIX and Flu vaccine to right thigh on 2/20/18. Parent states patient had tactile fever after vaccine but none noted the day of office visit. MD notes indicate "13x10 cm oval erythematous raised warm on dorsal aspect of right thigh, non-tender. Per Dr. when evaluated 2/22/18.
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site movement impairment, Injection site swelling, Pyrexia, Tenderness
Clinical narrative: Fever, swelling, redness at injection site, tenderness and mother states that patient "will not move his leg".
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site papule
Clinical narrative: R thigh with 5 raised papules in circular distribution at injection site.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Urticaria
Clinical narrative: Pt has small red itching whelps all over body.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Loss of consciousness, Muscle rigidity, Syncope
Clinical narrative: 02/19/18 at 3:00pm Mom reports pt has hx of passing out after receiving vaccine. He was placed in exam room to receive vaccines. Laying down on exam table he received 2 immunizations. Mom reports after received vaccines he had a syncope episode and his upper extremities were rigid. This was not witnessed by a nurse. Mom encouraged to follow up with pediatrician.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 5 cm x 3 cm erythematous, swollen area to left, posterior, upper arm. States area is itchy. Taking BENADRYL and applying topical cortisone cream 4 times/day.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: SKIN ERUPTION IN BOTH FOREARMS (NOT A BIG AREA).
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Cortical dysplasia, Electroencephalogram abnormal, Infantile spasms, Nuclear magnetic resonance imaging brain abnormal, Seizure
Clinical narrative: I have twins that were given their 2 month vaccinations. About a week later, both babies started having seizures. They were diagnosed with infantile spasms. One was diagnosed with a cortical dysplasia as well.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to a patient of unknown age and gender. On 25-NOV-2013, the patient was vaccinated with first dose of M-M-R II (therapy type, strength, dose, lot number, expiry date and route unspecified) for prophylaxis. On 08-AUG-2017, the patient was vaccinated with second dose of M-M-R II (therapy type, strength, dose, lot number, expiry date and route unspecified) for prophylaxis. On 06-FEB-2018 the patient was vaccinated with third dose of M-M-R II (strength, dose and therapy type unspecified) lot # M044350 and expiry date: 04-NOV-2018, subcutaneously for prophylaxis. No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 15-FEB-2018, the patient was vaccinated with an expired dose of ZOSTAVAX vial (strength, dose were not reported) (lot # M042850, expiry date: 18-JAN-2018) subcutaneously for prophylaxis. The administered dose of ZOSTAVAX was reconstituted with sterile diluent (manufacturer unknown). No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. The patient's concomitant medications included sterile diluent. On 20-FEB-2018, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 19400 plaque forming units (PFU), lot # M042851 with expiration date 18-FEB-2018, for prophylaxis (route of administration was not provided). No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a identifiable adult patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On December 2017, the patient was vaccinated with pediatric dose of VAQTA lot # N017094 expiry date 31-AUG-2018 by intramuscular route for prophylaxis (drug administered to patient of inappropriate age). No adverse effects reported. This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1802USA012041: US-009507513-1802USA012042.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a identifiable adult patient.  The patient's medical history, concurrent condition and concomitant medications were not reported. On December 2017, the patient was vaccinated with pediatric doses of VAQTA lot # N017094 expiry date 26-MAY-2018 by intramuscular route for prophylaxis. No adverse effects reported. This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1802USA012042: US-009507513-1802USA011849.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a identifiable adult patient.  The patient's medical history, concurrent condition and concomitant medications were not reported. On 15-DEC-2017, the patient was vaccinated with first pediatric dose of VAQTA lot # N017094 expiry date 31-AUG-2018 by intramuscular route for prophylaxis (drug administered to patient of inappropriate age). On 17-FEB-2018, the patient was vaccinated with second pediatric dose of VAQTA lot # N017094 expiry date 02-SEP-2018 by intramuscular route for prophylaxis (drug administered to patient of inappropriate age). No adverse effects reported. This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1802USA011849: US-009507513-1802USA012041.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck (manufacturer control number 00737850) from a contactable medical assistant. A female patient of unspecified age, race and ethnicity was vaccinated with one single dose of PREVNAR 13 for immunization on 13Oct2016. The patient began experiencing "redness, itching and swelling at the injection site" on an unspecified date after having received the vaccine. It was unknown if "redness, itching and swelling at the injection site" have resolved. No further information provided. The information on the lot number has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Temp to 100.6 Rectal. No redness or soreness at site of inj.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Mild local reaction only: red indurated 4 x 3 cm area at injection site.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Nausea, Urine analysis normal
Clinical narrative: Headache and nausea.
Age: 7.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Dtap vaccine given instead of Tdap vaccine recommended for age. No adverse reactions. Per guidelines, no need to re-vaccinate.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received two vaccines in right arm intramuscular injections on 2/22/18. By the end of the evening mother had noticed swelling and redness around the injection site. States the size of a quarter. By morning patient had complained of pain in right area where injection site is. Mother then noticed the redness, warmth, and swelling spreading to a larger area about the size of an orange. She contacted patients primary care physician and has an appointment scheduled so we could better evaluate the patient. As patient was being seen in the office it was determined that the patient had an adverse event to the vaccines given. Dr ordered 8 mg of DECADRON to be administered intramuscularly in the patients left thigh. She also prescribed hydroxyzine 10 mg to be taken by mouth every 8 hours for four days and prednisone 20 mg and patient is to take 1.5 tablets by mouth twice a day for three days. A recheck has also been scheduled so we may closely monitor this patient.
Age: 19.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Unevaluable event
Clinical narrative: MENACTRA given to 19 year old female. Guidelines state maximum age is 18 years old unless pre-existing medical conditions indicate otherwise.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Gave patient Flu vaccine that was not ordered by a physician because the patient had gotten one a week ago and patient did not need two doses of FLUARIX this season.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Redness and inflammation on same arm as vaccination below the vaccination area. Patient seen by physician, did not think it was caused by injection. Prescribed Triamcinolone cream and sulfamethoxazole for 10 days.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: Bicep to forearm areas of redness, swelling, heat, and pain. No reaction at injection site.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Crying
Clinical narrative: The child had a 9-month WELL CHILD visit on 2/22/18. At that time, she refused the patient getting #2 flu shot. She told the provider that after the child got her 6-month shots, and flu shot #1, that she had unconsolable crying for 8-hours. However, the mother did not call and report this to anyone at the time, nor did seek medical attention.
Age: 54.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Injection site erythema, Injection site inflammation
Clinical narrative: Approximately 10-15 minutes after administration the patient reported being "itchy everywhere." Upon examination there was erythema, warmth and inflammation at the site of injection on the right arm, soon followed by a rash all over the arm. The rash appeared as small red spots (non-raised). Vitals were WNL except for a slightly elevated BP. After approximately 5 minutes, the patient began to report difficulty breathing and chest tightness. At this time the patient received one epinephrine injection (via EPIPEN). After administration of epinephrine, the patient's symptoms resolved.  Approximately 45 minutes after epinephrine administration, patient received prednisone 50 mg PO x 1. She was discharged from the clinic with a short course of prednisone.
Age: 54.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Injection site warmth, Pruritus generalised, Rash, Rash erythematous
Clinical narrative: Approximately 10-15 minutes after administration the patient reported being "itchy everywhere." Upon examination there was erythema, warmth and inflammation at the site of injection on the right arm, soon followed by a rash all over the arm. The rash appeared as small red spots (non-raised). Vitals were WNL except for a slightly elevated BP. After approximately 5 minutes, the patient began to report difficulty breathing and chest tightness. At this time the patient received one epinephrine injection (via EPIPEN). After administration of epinephrine, the patient's symptoms resolved.  Approximately 45 minutes after epinephrine administration, patient received prednisone 50 mg PO x 1. She was discharged from the clinic with a short course of prednisone.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: KINRIX-PATIENT HAD LOCALIZED SWELLING TO THE RIGHT ARM, RED IN COLOR AND WARM TO THE TOUCH MEASURMENT OF SWELLING IN LENGTH IS 8.5 INCHES AND IN CIRCUMFERENCE 10.75 INCHES LONG. PROQUAD-PATIENT HAD LOCALIZED SWELLING TO THE LEFT ARM, RED IN COLOR MEASURMENT IS 1.5 INCHES IN LENGTH AND 1.5 INCHES IN CURCUMFERENCE.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-FEB-2018, the patient was vaccinated with an improperly stored dose of VARIVAX, lot N026075 and expiration date on 20-SEP-2019, for prophylaxis (dose, route of administration and anatomical location were not reported). The sterile diluent (MERCK) used to reconstitute the vaccine was properly stored. The administered dose of the vaccine experienced a temperature excursion of 11°F for 45 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, and concomitant medications. On or about 27-JUL-2012, the patient received ZOSTAVAX for its intended purpose: the prevention of shingles.  As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash, and lesions to various parts of his body.  The patient did not have a shingles outbreak until 08-JUN-2017. As a direct result of ZOSTAVAX, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries.  Further, he suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the event was unknown at the time of reporting. Causality assessment was related. The lawyer considered shingles outbreak/chronic pain, rash and lesions to various parts of his body to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, and concomitant medications. On or about 17-APR-2014, the patient received ZOSTAVAX for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash, and lesions to various parts of his body. The patient did not have a shingles outbreak until 26-JUN-2017.  As a direct result of ZOSTAVAX, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, he suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the event was unknown at the time of reporting.  Causality assessment was related. The lawyer considered shingles outbreak/chronic pain, rash and lesions to various parts of his body to be disabling. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Injection site rash, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Anthrax immunization, dose #5. Shoulder pain for 3 months with limited ROM. Pain and rash at the site. Complete recovery per visit in Aug, 2009. Discussed with agency Support Center. Given exemption.
Age: 24.0
Sex: M
Vaccine: ANTH, HPV9, SMALL
Symptoms: Basophil percentage increased, Eosinophil percentage, Fatigue, Generalised vaccinia, Haematocrit normal
Clinical narrative: PATIENT NOTICED SIGNIFICANT SWELLING, REDNESS, AND YELLOW/GREEN DISCHARGE AT INJECTION SITE AS WELL AS RASH ON CHEST, BACK, NECK, ARMS, AND RIGHT LEG WHEN HE WOKE ON 21 FEB 2018. HE ADDITIONALLY HAD MILD CONSTITUTIONAL SYMPTOMS OF GENERALIZED FATIGUE AND BODY ACHES. HE PRESENTED TO THE CLINIC FOR EVALUATION AND THE INJECTION SITE WAS NOTED TO HAVE APPEARANCE OF ROBUST TAKE. THE DIFFUSE RASH HAD APPEARANCE OF GENERALIZED VACCINIA. HE HAS NO H/O IMMUNE COMPROMISING CONDITION OR MEDICATION. HE HAD AN OTHERWISE NORMAL EXAM. HE WAS MANAGED SYMPTOMATICALLY WITH DIPHENHYDRAMINE AND IBUPROFEN. HE FOLLOWED UP ON 23 FEB 2018 AND REPORTED THAT THE LESIONS HAD TURNED INTO PUSTULES, RUPTURED, AND SCABBED.
Age: 24.0
Sex: M
Vaccine: ANTH, HPV9, SMALL
Symptoms: Haemoglobin normal, Injection site discharge, Injection site erythema, Injection site swelling, Lymphocyte percentage
Clinical narrative: PATIENT NOTICED SIGNIFICANT SWELLING, REDNESS, AND YELLOW/GREEN DISCHARGE AT INJECTION SITE AS WELL AS RASH ON CHEST, BACK, NECK, ARMS, AND RIGHT LEG WHEN HE WOKE ON 21 FEB 2018. HE ADDITIONALLY HAD MILD CONSTITUTIONAL SYMPTOMS OF GENERALIZED FATIGUE AND BODY ACHES. HE PRESENTED TO THE CLINIC FOR EVALUATION AND THE INJECTION SITE WAS NOTED TO HAVE APPEARANCE OF ROBUST TAKE. THE DIFFUSE RASH HAD APPEARANCE OF GENERALIZED VACCINIA. HE HAS NO H/O IMMUNE COMPROMISING CONDITION OR MEDICATION. HE HAD AN OTHERWISE NORMAL EXAM. HE WAS MANAGED SYMPTOMATICALLY WITH DIPHENHYDRAMINE AND IBUPROFEN. HE FOLLOWED UP ON 23 FEB 2018 AND REPORTED THAT THE LESIONS HAD TURNED INTO PUSTULES, RUPTURED, AND SCABBED.
Age: 24.0
Sex: M
Vaccine: ANTH, HPV9, SMALL
Symptoms: Monocyte percentage increased, Neutrophil percentage, Pain, Platelet count normal, Rash
Clinical narrative: PATIENT NOTICED SIGNIFICANT SWELLING, REDNESS, AND YELLOW/GREEN DISCHARGE AT INJECTION SITE AS WELL AS RASH ON CHEST, BACK, NECK, ARMS, AND RIGHT LEG WHEN HE WOKE ON 21 FEB 2018. HE ADDITIONALLY HAD MILD CONSTITUTIONAL SYMPTOMS OF GENERALIZED FATIGUE AND BODY ACHES. HE PRESENTED TO THE CLINIC FOR EVALUATION AND THE INJECTION SITE WAS NOTED TO HAVE APPEARANCE OF ROBUST TAKE. THE DIFFUSE RASH HAD APPEARANCE OF GENERALIZED VACCINIA. HE HAS NO H/O IMMUNE COMPROMISING CONDITION OR MEDICATION. HE HAD AN OTHERWISE NORMAL EXAM. HE WAS MANAGED SYMPTOMATICALLY WITH DIPHENHYDRAMINE AND IBUPROFEN. HE FOLLOWED UP ON 23 FEB 2018 AND REPORTED THAT THE LESIONS HAD TURNED INTO PUSTULES, RUPTURED, AND SCABBED.
Age: 24.0
Sex: M
Vaccine: ANTH, HPV9, SMALL
Symptoms: Rash pustular, Robust take following exposure to vaccinia virus, Scab, Skin lesion, White blood cell count normal
Clinical narrative: PATIENT NOTICED SIGNIFICANT SWELLING, REDNESS, AND YELLOW/GREEN DISCHARGE AT INJECTION SITE AS WELL AS RASH ON CHEST, BACK, NECK, ARMS, AND RIGHT LEG WHEN HE WOKE ON 21 FEB 2018. HE ADDITIONALLY HAD MILD CONSTITUTIONAL SYMPTOMS OF GENERALIZED FATIGUE AND BODY ACHES. HE PRESENTED TO THE CLINIC FOR EVALUATION AND THE INJECTION SITE WAS NOTED TO HAVE APPEARANCE OF ROBUST TAKE. THE DIFFUSE RASH HAD APPEARANCE OF GENERALIZED VACCINIA. HE HAS NO H/O IMMUNE COMPROMISING CONDITION OR MEDICATION. HE HAD AN OTHERWISE NORMAL EXAM. HE WAS MANAGED SYMPTOMATICALLY WITH DIPHENHYDRAMINE AND IBUPROFEN. HE FOLLOWED UP ON 23 FEB 2018 AND REPORTED THAT THE LESIONS HAD TURNED INTO PUSTULES, RUPTURED, AND SCABBED.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Rash / hives, itching on arms legs stomach back hands feet 02/22/2018 at 6:30 am.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Pallor, Rash macular
Clinical narrative: Macular blanching rash on lower extremities and forehead shortly after vaccine administration. Gave BENADRYL 1/2 tsp and rash began to resolve almost immediately.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Food allergy, Pruritus
Clinical narrative: Patient reported to pharmacy that she thinks she is allergic to acidic food items now, like spaghetti sauce, oranges, dill pickles, orange juice  Patient says she cannot eat those items ever since shot without having excessive itching.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Patient called 2/5/18 to report that she had redness, swelling, and itching on inner aspect of vaccine arm from armpit to elbow. Reaction began day after vaccine received and lasted for 3 days then resolved. Patient did take antihistamine. No breathing troubles reported.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Patient called 2/5/18 to report that she had redness, swelling, and itching on inner aspect of vaccine arm from armpit to elbow. Reaction began day after vaccine received and lasted for 3 days then resolved. Patient did take antihistamine. No breathing troubles reported.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: Patient came in pharmacy on February 23, 2018 wanting to know which flu immunization he received. He stated he had vision changes (can't read small print) since January 2018 and immunization was given 10/16/2017. He stated he had went to his eye dr and had his vision checked and he thinks it's possibly coming from the influenza vaccine he received.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Induration, Skin discolouration
Clinical narrative: Area of discoloration and induration measuring 2 cm in diameter with circular shape. No evidence of blush, hot, baseline pain. Patient afebrile. No symptoms other than possible tenderness to palpation.
Age: 14.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Back pain, Pain in extremity
Clinical narrative: Per pt arms started to hurt around 1030am while at school and she called dad. By then her legs and back also started to  hurt. Dad called office and was advised to take her to the ER.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Developed a few hives while sleeping. Treated with a little hydrocortisone cream. Hives were gone next morning. Didn't seek medical care.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Full blood count, Induration, Skin lesion, Ultrasound scan
Clinical narrative: Lesion measuring 1.2 cm in elevation and 1.5 cm in diameter. Firm to touch with no associated fluctuance. No drainage. Erythematous. No associated hot. Ultrasound: A region of increased echogenicity, which is moderately demarcated from adjacent subcutaneous fat, is demonstrated anteriorly in the right thigh, corresponding to the palpable abnormality. It measures 7.8 x 6.8 x 4.5 mm. A portion of the center is slightly more hypoechoic, but no significant fluid is identified within the region. A small linear collection of fluid may be present deep to this region. Findings are most consistent with a region of induration/reactive change. A drainable abscess is not identified. This apparently corresponds with a region of a vaccination.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Localized redness on arm. Hot to the touch. Patient stated it was "itchy." Patient was seen on 2/23/2018; by this date the redness had minimized significantly and it was not painful. Parents put over the counter BENADRYL lotion to help with the itching on 2/22/2018. Dr. prescribed ATARAX 6ml PO Q6H PRN for itching.
Age: 33.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Diarrhoea, Fatigue, Gastrointestinal disorder, Urticaria, Vomiting
Clinical narrative: 12/1/16: about 5pm - hives started; 5:30pm - hives spread to most of upper body (including ears and scalp), started to get GI issues; 7:00pm hives on entire body, severe GI issues with simultaneous vomiting and diarrhea; 12/2/16: approximately 2:00am symptoms were gone, left feeling only fatigue.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This patient's arm was severely swollen.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Pain, Pyrexia
Clinical narrative: Low grade fever, chills, sore all over, lethargy; resolved by the next morning.
Age: 33.0
Sex: F
Vaccine: TTOX
Symptoms: Blood test normal, Chest pain, Chills, Confusional state, Dizziness
Clinical narrative: Fever and chills, severe body aches and pain, loopy/dizzy, confused, swollen and red injection site, tired, confused, chest pains, headache.
Age: 33.0
Sex: F
Vaccine: TTOX
Symptoms: Fatigue, Headache, Hypertension, Injection site erythema, Injection site swelling
Clinical narrative: Fever and chills, severe body aches and pain, loopy/dizzy, confused, swollen and red injection site, tired, confused, chest pains, headache.
Age: 33.0
Sex: F
Vaccine: TTOX
Symptoms: Pain, Pyrexia
Clinical narrative: Fever and chills, severe body aches and pain, loopy/dizzy, confused, swollen and red injection site, tired, confused, chest pains, headache.
Age: 53.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Nuchal rigidity
Clinical narrative: Patient reports having nuchal rigidity starting 1 week after administration of MENACTRA and BEXSERO. Currently, this stiffness is just starting to resolve. Overall he has had nuchal rigidity for 3-4 weeks now. This was also accompanied by a HA during the first 4 days when rigidity started. Called the DCD and there is no record of this ADR. Patient has had reactions in the past to receiving 2 vaccines in one day. Do not feel comfortable with pt getting 2nd series so will discontinue. Patient agrees. Will enter ADR.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 52-year-old male patient who received SHINGRIX. On 14th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th February 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 15th February 2018, the patient experienced injection site pain and shivering. On an unknown date, the outcome of the injection site pain and shivering were recovering/resolving and the outcome of the vaccine administered at inappropriate site was unknown. The reporter considered the injection site pain and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient was about 52 years old, but the sales representative did not know the exact year of his birth. At 15:00, the patient was administered SHINGRIX vaccine on an unknown arm in the tricep instead of the deltoid, which led to vaccine administered at inappropriate site. One day after receiving vaccination, the patient stated that his tricep was really, really sore and he was experiencing some shivering. The patient was told by his pharmacy to come back in 1 month for the 2nd dose of SHINGRIX.
Age: 79.0
Sex: F
Vaccine: FLU4, FLUA3
Symptoms: Abdominal pain upper, Computerised tomogram abdomen normal, Computerised tomogram pelvis, Erythema, Pain in extremity
Clinical narrative: The spot turned red and swelling of arms and swelling of upper chest under breast, and stomach. A lot of pain in arm. It is now going on 4 weeks and still swollen and hurt.
Age: 79.0
Sex: F
Vaccine: FLU4, FLUA3
Symptoms: Peripheral swelling, Swelling, Ultrasound scan normal
Clinical narrative: The spot turned red and swelling of arms and swelling of upper chest under breast, and stomach. A lot of pain in arm. It is now going on 4 weeks and still swollen and hurt.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Injection site pain
Clinical narrative: 3 weeks after injection, developed pain and induration at injection site. No erythema or infection.
Age: 0.5
Sex: F
Vaccine: TDAP
Symptoms: Abnormal behaviour, Accidental underdose, Diarrhoea, Drug administered to patient of inappropriate age, Feeling abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 6-month-old female patient who received BOOSTRIX (batch number 4L972, expiry date 11th May 2018). On 7th February 2018, the patient received BOOSTRIX. On 7th February 2018, less than a day after receiving BOOSTRIX, the patient experienced fever, fuzzy, insomnia, behavior abnormal, vomiting, diarrhea, accidental underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the fever, fuzzy, insomnia, behavior abnormal, vomiting and diarrhea were recovering/resolving and the outcome of the accidental underdose and inappropriate age at vaccine administration were unknown. The reporter considered the fever, fuzzy, insomnia, behavior abnormal, vomiting and diarrhea to be related to BOOSTRIX. Additional details were provided as follows: The patient's father reported that his daughter (patient) was administered a dose of BOOSTRIX at an age of 6 months by mistake, which led to accidental underdose and inappropriate age at vaccine administration. The nurse gave the shot to the patient. On 7th February 2018 (on the same day), the patient received several vaccines, but reporter did not have the name of the other vaccines at the time of reporting. On 7th February 2018 (on the same day), the patient had experienced several symptoms received the vaccine. The patient was feeling better at the time of reporting. This case was an accidental medication error associated with adverse events.
Age: 0.5
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 6-month-old female patient who received BOOSTRIX (batch number 4L972, expiry date 11th May 2018). On 7th February 2018, the patient received BOOSTRIX. On 7th February 2018, less than a day after receiving BOOSTRIX, the patient experienced fever, fuzzy, insomnia, behavior abnormal, vomiting, diarrhea, accidental underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the fever, fuzzy, insomnia, behavior abnormal, vomiting and diarrhea were recovering/resolving and the outcome of the accidental underdose and inappropriate age at vaccine administration were unknown. The reporter considered the fever, fuzzy, insomnia, behavior abnormal, vomiting and diarrhea to be related to BOOSTRIX. Additional details were provided as follows: The patient's father reported that his daughter (patient) was administered a dose of BOOSTRIX at an age of 6 months by mistake, which led to accidental underdose and inappropriate age at vaccine administration. The nurse gave the shot to the patient. On 7th February 2018 (on the same day), the patient received several vaccines, but reporter did not have the name of the other vaccines at the time of reporting. On 7th February 2018 (on the same day), the patient had experienced several symptoms received the vaccine. The patient was feeling better at the time of reporting. This case was an accidental medication error associated with adverse events.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient left arm became painful and she observed swelling and redness at the site of injection the following morning after she received vaccines. She returned to the clinic 24 hours after she first noticed the swelling. I observed an area of induration approximately 7 cm in diameter with redness and swelling, mild to moderate pain with palpation. Cold pack applied for 15 minutes, and ibuprofen administered. Pain and swelling decreased but remain evident.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Insomnia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of difficulty sleeping in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced difficulty sleeping, fever, influenza-like symptoms and headache. On an unknown date, the outcome of the difficulty sleeping, fever, influenza-like symptoms and headache were recovered/resolved. It was unknown if the reporter considered the difficulty sleeping, fever, influenza-like symptoms and headache to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The health care professional reported that difficulty sleeping at night (05 unit not specified) following receipt of SHINGRIX. Upon waking the following morning, the patient noted headache, low-grade fever, and flu-like symptoms. The health care professional did not have time to discuss in detail. It was unable to obtain all necessary information regarding incident (lot or expiry, date of birth, relatedness to vaccine, etc).
Age: 62.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Asthenia, Dizziness, Muscle spasms, Muscle tightness, Product quality issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 62-year-old male patient who received RABAVERT (batch number 645011A, expiry date 30th September 2020). On 27th January 2018, the patient received RABAVERT 1 ml. On 27th January 2018, less than a day after receiving RABAVERT, the patient experienced dizziness, cervical spasm, weakness and tightness of jaw muscles. On an unknown date, the patient experienced nonspecific reaction and pharmaceutical product complaint. On an unknown date, the outcome of the dizziness and weakness were unchanged and the outcome of the cervical spasm and tightness of jaw muscles were recovering/resolving and the outcome of the nonspecific reaction and pharmaceutical product complaint were unknown. The reporter considered the dizziness, cervical spasm, weakness, tightness of jaw muscles and nonspecific reaction to be almost certainly related to RABAVERT. Additional details were provided as follows: The patient reported that the RABAVERT vaccine had caused weakness, dizziness, tightness of jaw muscles, and a crick in his neck. The patient was received the RABAVERT as his choice to bring up his titers. He was not at risk in his occupation. The physician which filled QA report stated that the patient reported that he suspected his lot of RABAVERT might be suspect. The patient had experienced adverse drug reactions with this specific unit compared to other injections received. The patient did not have the suspect vaccine but had the lot number. The patient would like to know if this vaccine accidentally had live virus put in it and also wants to know if the production run was faulty. The patient called back inquiring about a lot number from a RABAVERT vaccine and asked if there were any issues reported with the particular lot he provided and the call receiver informed caller that if there were any issues with the vaccine, then there would be a recall, but there had not been a recall for the vaccine. The patient further stated that he has had some reactions to the vaccine, but that he would rather not provide what reactions he has had because they were scary. He was not hospitalized for any of the events. The patient did not provide any additional information.
Age: 62.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 62-year-old male patient who received RABAVERT (batch number 645011A, expiry date 30th September 2020). On 27th January 2018, the patient received RABAVERT 1 ml. On 27th January 2018, less than a day after receiving RABAVERT, the patient experienced dizziness, cervical spasm, weakness and tightness of jaw muscles. On an unknown date, the patient experienced nonspecific reaction and pharmaceutical product complaint. On an unknown date, the outcome of the dizziness and weakness were unchanged and the outcome of the cervical spasm and tightness of jaw muscles were recovering/resolving and the outcome of the nonspecific reaction and pharmaceutical product complaint were unknown. The reporter considered the dizziness, cervical spasm, weakness, tightness of jaw muscles and nonspecific reaction to be almost certainly related to RABAVERT. Additional details were provided as follows: The patient reported that the RABAVERT vaccine had caused weakness, dizziness, tightness of jaw muscles, and a crick in his neck. The patient was received the RABAVERT as his choice to bring up his titers. He was not at risk in his occupation. The physician which filled QA report stated that the patient reported that he suspected his lot of RABAVERT might be suspect. The patient had experienced adverse drug reactions with this specific unit compared to other injections received. The patient did not have the suspect vaccine but had the lot number. The patient would like to know if this vaccine accidentally had live virus put in it and also wants to know if the production run was faulty. The patient called back inquiring about a lot number from a RABAVERT vaccine and asked if there were any issues reported with the particular lot he provided and the call receiver informed caller that if there were any issues with the vaccine, then there would be a recall, but there had not been a recall for the vaccine. The patient further stated that he has had some reactions to the vaccine, but that he would rather not provide what reactions he has had because they were scary. He was not hospitalized for any of the events. The patient did not provide any additional information.
Age: 62.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Throat tightness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 62-year-old male patient who received RABAVERT (batch number 645011A, expiry date 30th September 2020). On 27th January 2018, the patient received RABAVERT 1 ml. On 27th January 2018, less than a day after receiving RABAVERT, the patient experienced dizziness, cervical spasm, weakness and tightness of jaw muscles. On an unknown date, the patient experienced nonspecific reaction and pharmaceutical product complaint. On an unknown date, the outcome of the dizziness and weakness were unchanged and the outcome of the cervical spasm and tightness of jaw muscles were recovering/resolving and the outcome of the nonspecific reaction and pharmaceutical product complaint were unknown. The reporter considered the dizziness, cervical spasm, weakness, tightness of jaw muscles and nonspecific reaction to be almost certainly related to RABAVERT. Additional details were provided as follows: The patient reported that the RABAVERT vaccine had caused weakness, dizziness, tightness of jaw muscles, and a crick in his neck. The patient was received the RABAVERT as his choice to bring up his titers. He was not at risk in his occupation. The physician which filled QA report stated that the patient reported that he suspected his lot of RABAVERT might be suspect. The patient had experienced adverse drug reactions with this specific unit compared to other injections received. The patient did not have the suspect vaccine but had the lot number. The patient would like to know if this vaccine accidentally had live virus put in it and also wants to know if the production run was faulty. The patient called back inquiring about a lot number from a RABAVERT vaccine and asked if there were any issues reported with the particular lot he provided and the call receiver informed caller that if there were any issues with the vaccine, then there would be a recall, but there had not been a recall for the vaccine. The patient further stated that he has had some reactions to the vaccine, but that he would rather not provide what reactions he has had because they were scary. He was not hospitalized for any of the events. The patient did not provide any additional information.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral candidiasis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of oral thrush in a 56-year-old female patient who received SHINGRIX. Concurrent medical conditions included breast cancer. Concomitant products included letrozole. On 19th February 2018, the patient received SHINGRIX. On 20th February 2018, 1 days after receiving SHINGRIX, the patient experienced oral thrush. On an unknown date, the outcome of the oral thrush was not recovered/not resolved. It was unknown if the reporter considered the oral thrush to be related to SHINGRIX. Additional details were provided as follows: The health care professional called to report that the patient who received the SHINGRIX vaccine developed oral thrush the following morning. The health care professional did not have vaccine lot number or expiry date and no date of birth of the patient was reported.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site swelling and redness. Loratadine 10 mg prn.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza, Injection site pain, Middle insomnia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, Atorvastatin, lisinopril and Metformin. On 15th February 2018, the patient received the 1st dose of SHINGRIX. On 15th February 2018, 4 hrs after receiving SHINGRIX, the patient experienced injection site pain, general body pain and influenza. The patient was treated with ADVIL. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the general body pain was recovering/resolving and the outcome of the influenza was unknown. The reporter considered the injection site pain and general body pain to be related to SHINGRIX. It was unknown if the reporter considered the influenza to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine at approximately 2:00 pm in left arm. Four to 5 hours later the patient felt injection site soreness and took ADVIL. The patient woke up at 5:00 am with total body aches. He said he felt like he had the flu. He thought the body aches presented while he was sleeping and were so bad by 5:00 am that it woke him up. He took ADVIL. He felt much better now than he did this morning.
Sex: F
Vaccine: VARZOS
Symptoms: Administration site swelling, Injection site erythema, Injection site pruritus
Clinical narrative: The patient complains of redness, swelling, and itching over an area of 2-3" surrounding administration area and worsening symptoms of day 3 post administration.
Age: 1.17
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Erythema, Urticaria
Clinical narrative: Following day, red, mosquito-bite like whelps all over body.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: (R) arm swelling and tenderness from mid upper arm to hand began 2 days after vaccine, no rash. Recommended ibuprofen, cold compress and update in AM.