chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 27-AUG-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, (dose and frequency were not provided), lot # K019370, expiration date 16-JUL-2016. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source, Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates since 12-MAY-2015, multiple unspecified patients were vaccinated with unspecified doses of improperly stored GARDASIL (lot # K001500, expiry date 06-NOV-2016; lot # K003520, expiry date 20-NOV-2016; lot # K006124, expiry date 02-FEB-2017) (dosage, strength and route were not reported). At the time of the report, there was no adverse effects reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a field employee refers to a 54 year old female patient. The patient's pertinent medical history and drug allergies were unspecified. On 01-SEP-2015, the patient was vaccinated with ZOSTAVAX, (route, dose and anatomical location not reported). On 02-SEP-2015 (reported as the following day after administration), the patient experienced swelling and rash at the injection site. The patient sought medical attention by speaking to the physician. The outcome of swelling and rash at the injection site. The causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX (lot#, dose, dose number, route were unspecified). Then on unspecified dates, the patients had a red, swollen area the size of a quarter at the ZOSTAVAX injection site. The pharmacist did not have any further information to provide regarding these patients. The outcome of the event was unknown. This is one of the two reports that received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 28-AUG-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ orally (dose and frequency were not provided), lot # K019370, expiration date 16-JUL-2016. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 21-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # K005428, expiry date 15-APR-2016 (administration site and root were not reported). No adverse effects were reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, Rash
Clinical narrative: This spontaneous report was received from a health care worker, patient's mother via field representative referring to a 14 year old male patient. The patient's pertinent medical history and drug allergies were unspecified. The patient was vaccinated with first dose of GARDASIL sometime in June 2013 and the second dose of GARDASIL sometime in September 2013. The patient received the third dose of GARDASIL 9 intramuscularly in the left arm for prevention of HPV in August 2015. Concomitant medications included an unspecified flu shot. The patient's paediatrician reported that approximately in August 2015 (reported as 7 to 8 days after vaccination), the patient experienced a rash in his groin area and it was approaching his lower abdominal area (rash generalised). It was confirmed that the first two doses were GARDASIL and the third dose of GARDASIL 9. The patient sought medical attention, visited office. The patient was treated with BENADRYL, CLARITIN and an unspecified cortisol cream. The patient was recovering from rash. The reporter had not provide the causality assessment for the event. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date of March 2015 (reported as 6 months ago), the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (dose, frequency, route and lot# were not reported) (drug administration error). The patient reported a Merck product could not be ruled out. On an unknown date, the patient contracted pneumonia. The outcome of pneumonia was not reported. The causality was not provided. Additional information is not expected as there was no any contact information reported.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 28-AUG-2015 the patient was vaccinated with an improperly stored dose of oral, ROTATEQ (dose and frequency were not provided), lot # reported as K022993, expiration date 20-JUL-2016. No concomitant medication was reported. At the time of this report, no adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 28-AUG-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, (dose and frequency were not provided), lot # reported as K022993, expiration date 20-JUL-2016. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 28-AUG-2015 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, (dose and frequency and route of administration were not provided), lot # reported as L020157, expiration date 12-MAR-2018. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 31-AUG-2015 the patient was vaccinated with an improperly stored dose of oral, ROTATEQ, (dose and frequency were not provided), lot # K019370, expiration date 16-JUL-2016. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 27-AUG-2015 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, frequency and route of administration were not provided), lot # reported as L020157, expiration date 12-MAR-2018. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: One week after immunization patient developed a large red hive at injection site. Size is 2 in x 4 in.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via a inside sales representative refers to a female patient of unknown age. The patient's medical history and drug reactions were not specified by the reporter. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (1 vial, route of administration, lot# and expiration date were not reported). The patient's concomitant therapy was not specified by the reporter. On an unknown date (thirty days after the patient received the vaccine), she broke out in a rash. It was unspecified exactly where the rash was at that time. The patient was treated with unspecified oral steroids, with no improvement. The patient sought medical attention by having multiple trips to an unspecified Emergency Facility. The rash was spreading and covered the patient's entire upper torso. The outcome of rash was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema, Injected limb mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Pt's (L) arm was swollen, red, hot to touch and decrease in ROM. Pt. was treated with a 10 day course of abx. (KEFLEX).
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Headache, Vision blurred
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 15 year old female patient with asthma. There were no drug allergies/reactions. On 09-SEP-2015, the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, dose and route not reported) in her arm to prevent VAQTA (lot #, expiration date, dose and route not reported) in the opposite arm. Concomitant therapies included ondansetron, albuterol sulfate (manufacturer unknown), PROZAC, chlorpheniramine maleate, ibuprofen, ADVIL ALLERGY SINUS, WELLBUTRIN XL, ABILIFY, hydroxyzine and melatonin. On 09-SEP-2015, the patient developed blurred vision and a sharp headache in the office. The patient was instructed to lie down for "a few" minutes and she then appeared "to be fine". No lab diagnostics studies were performed. The outcome of vision blurred and headache was resolved on the same day. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Papule
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 31 year old female patient. No information regarding the patient's medical history or concurrent conditions was provided. On 01-SEP-2015, the patient was vaccinated with a dose of MMR II injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. On an unknown date, approximately in September 2015, the patient experienced "papules on her lateral thighs, butt, arms and groin". It was reported that the patient had been using a depilatory cream on these same areas prior to receiving the vaccine. The patient sought medical attention by showing up in the reporter's office on 08-SEP-2015. There was no product quality complaint (PQC) involved. The outcome of the event was not reported. The relatedness between MMR II and the event was not provided. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Conjunctival hyperaemia, Erythema, Lip swelling, Periorbital oedema, Skin test negative
Clinical narrative: On 6 April 2015 (catch-up immunization due to lost medical coverage) patient received his first MMR and varicella vaccine in the form of PROQUAD (manufacturer Merck; Lot number K019100; 0.5 mL right thigh subcutaneously) as well as hepatitis a #1 (manufacturer Smithkline; Lot # 5CK4Y; 0.5 mL intramuscularly to the left thigh). Patient with no immediate adverse reactions. However, within one hour mother describes patient developing facial swelling to include periorbital edema and mild lip swelling as well as periorbital erythema and conjunctival injection. She specifically denies patient developing any tongue swelling, throat tightness, or any airway or vascular compromise. No associated generalize urticaria. No associated nausea, vomiting, or diarrhea. Mother denies patient with any other previous adverse reaction to vaccines. No known food allergies, or history of atopy such as asthma or eczema.
Age: 3.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Skin test positive, Swelling face
Clinical narrative: On 6 April 2015 (catch-up immunization due to lost medical coverage) patient received his first MMR and varicella vaccine in the form of PROQUAD (manufacturer Merck; Lot number K019100; 0.5 mL right thigh subcutaneously) as well as hepatitis a #1 (manufacturer Smithkline; Lot # 5CK4Y; 0.5 mL intramuscularly to the left thigh). Patient with no immediate adverse reactions. However, within one hour mother describes patient developing facial swelling to include periorbital edema and mild lip swelling as well as periorbital erythema and conjunctival injection. She specifically denies patient developing any tongue swelling, throat tightness, or any airway or vascular compromise. No associated generalize urticaria. No associated nausea, vomiting, or diarrhea. Mother denies patient with any other previous adverse reaction to vaccines. No known food allergies, or history of atopy such as asthma or eczema.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: Rash on left arm approximately 5" across 4 " tall with a slight itch no broken skin or scaling.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Acupuncture, Herpes zoster
Clinical narrative: This spontaneous report was received from an 82 year old female patient, reporting on herself. Patient's concurrent condition included high blood pressure. Medical history was not reported. Patient was allergic to VALTREX, penicillin and unspecified sulfa drugs. On 05-MAY-2009 the patient was vaccinated with 1 dose of ZOSTAVAX in the left arm. Concomitant therapies included SYNTHROID and unspecified blood pressure medication. On 15-AUG-2015 (also reported as years after getting the ZOSTAVAX vaccine), the patient developed shingles. Patient sought medical attention and was treated with VALTREX and acupuncture on an unspecified date. The outcome of event was unknown. Causality assessment was not provided. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates between 01-SEP-2015 and 09-SEP-2015, the patients were vaccinated with PEDVAXHIB (lot # K026532 and expiration date 07-AUG-2017, lot# L006545 and expiration date 16-NOV-2017, lot# L014427 and expiration date 09-MAR-2018) (dose and route were not reported) that were improperly stored. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates between 01-SEP-2015 and 09-SEP-2015, the patients were vaccinated with GARDASIL 9 (lot # L004104 and expiration date 04-MAR-2017, lot# L011846 and expiration date 16-JUN-2017, lot# K026246 and expiration date 28-JAN-2017) (dose and route were not reported) that were improperly stored. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB, lot# K021444, expiry date 17-SEP-2016, 0.5 specific dose (frequency unspecified), in the arm (deltoid). No adverse effects were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 lot # K026246, expiry date 28-JAN-2017, 0.5 specific dose (frequency unspecified), in the arm (deltoid). No adverse effects were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain, Swelling
Clinical narrative: Shot received 2:45 pm pain and swelling around 6 pm bruuse approximatrly 8 pm soreness also by bedtime - 10 pm.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh red, swollen and warm to touch.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Clostridium difficile colitis, Diarrhoea
Clinical narrative: Diarrhea x 2 days.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt reports developing redness and itchiness at the site of administration of vaccines: Rt upper arm; 09/04/15 -seen in office 8cm redness, swelling and warmth.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema multiforme, Rash
Clinical narrative: Rash developed on 9/3/15 appears to be erythema multiforme rashes - no fevers eating well so far.
Age: 18.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Gastroenteritis, Hepatitis A antibody positive, Hepatitis C
Clinical narrative: Patient presented to our office on 8/20/2015 with symptoms gastroenteritis with HCV, lab results, revealed extremely elevated ALT/AST further testing labs and Hep A.
Age: 18.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Hepatitis viral test
Clinical narrative: Patient presented to our office on 8/20/2015 with symptoms gastroenteritis with HCV, lab results, revealed extremely elevated ALT/AST further testing labs and Hep A.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL Lot # L004601; expiration date: 04-NOV-2016, Lot # K006960; expiration date: 19-FEB-2017 and Lot# K007828; expiration date: 02-MAR-2017. No adverse experiences reported for any patients. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 10-SEP-2015, the patient was inadvertently vaccinated with a dose of expired ZOSTAVAX lot # K000727, expiration date 30-JAN-2015 (dose and route of administration were not provided). No adverse effect was reported. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Blister, Cellulitis
Clinical narrative: Blistering, cellulitis.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies provided. On an unknown dates, the patients was vaccinated with improperly stored (reported as "post temperature excursion") PROQUAD (Merck) (lot# L016394, expiration date 08-SEP-2016, doses, site and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Muscular weakness, Pain
Clinical narrative: Weakness w/ lifting the arm. Pain lasted for weeks.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Concurrent conditions or pertinent medical history were not reported. On an unsepcified date in 2015 (reported as 4 or 5 days ago), the patient was vaccinated wiht a dose of ZOSTAVAX (lot #, dose, route of administration and frequency were unspecified). Concomitant medications were not reported. Approximately on Septemebr 2015, the patient received a prescription for prednisone (unspecified adverse event). The reporter stated that she did not know why the patient was prescribed the prednisone, however, she considered it was for a pre-existing condition and that the need for the medication was not related to the patient receiving ZOSTAVAX. At the time of the report, the outcome of adverse event was unknown. The relatedness between ZOSTAVAX and the unspecified adverse event was not related. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 30 year old male patient. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On an unknown date, there was an inappropriate schedule of drug administration as GARDASIL 9 had been administered beyond the recommended age range. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 33 year old male patient. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (route, lot number and expiration date were not provided). Concomitant therapy information was not provided. On an unknown date, there was an inappropriate schedule of drug administration as GARDASIL 9 had been administered beyond the recommended age range. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.27
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Hives from shoulder to wrist on (L) arm. Resolved after one dose of BENADRYL.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Headache, Vision blurred
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 year old female patient with none drug reactions or allergies. Pertinent medical history was not reported. On 03-MAR-2015 and on 05-MAY-2015, the patient was vaccinated with the first dose and second dose, respectively, of GARDASIL (Lot number, expiration date, route and dose were not provided). On 08-SEP-2015, the patient was vaccinated with the first dose (reported as the third dose) of GARDASIL 9 (Lot number, expiration date, route and dose were not provided). Concomitant medications were not reported. The reporter stated that within minutes after being vaccinated with GARDASIL 9, the patient developed blurred vision and a sharp headache. The patient was instructed to lie down in the office "for a few minutes" and to had a few sips of water to drink. No laboratory diagnostic studies were performed. The patient recovered of sharp headache and blurred vision on 08-SEP-2015. The reporter did not assess the relatedness of GARDASIL and GARDASIL 9 and GARDASIL to sharp headache and blurred vision. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache, chills, aches.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Blood creatinine normal, Blood lactic acid normal, Blood magnesium normal, Blood phosphorus normal, Computerised tomogram head normal
Clinical narrative: Child had sudden onset of "tonic" seizure at school; unresponsive x 7 minutes; B/P=240/167, HR > 200 per school nurse, taken to ER per mother; neurology consult pending; no fever or prior history of seizures.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Drug screen negative, Electrocardiogram normal, Haemoglobin normal, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: Child had sudden onset of "tonic" seizure at school; unresponsive x 7 minutes; B/P=240/167, HR > 200 per school nurse, taken to ER per mother; neurology consult pending; no fever or prior history of seizures.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Monocyte percentage, Neutrophil percentage increased, Protein urine present, Tonic convulsion, Unresponsive to stimuli
Clinical narrative: Child had sudden onset of "tonic" seizure at school; unresponsive x 7 minutes; B/P=240/167, HR > 200 per school nurse, taken to ER per mother; neurology consult pending; no fever or prior history of seizures.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Urine ketone body present, Urine leukocyte esterase positive
Clinical narrative: Child had sudden onset of "tonic" seizure at school; unresponsive x 7 minutes; B/P=240/167, HR > 200 per school nurse, taken to ER per mother; neurology consult pending; no fever or prior history of seizures.
Age: 1.03
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Body temperature increased, Crying, Ear infection, Full blood count, Haematocrit
Clinical narrative: 1945 pt began crying and seizing in crib. Seized  2-3 min. Mom called 911, pt transported to ER via ambulance. ER administered TYLENOL and amoxicillin (suspected ear infection). D/C from ER approximately 2200 same night. Temperature on arrival to ER: 103.7 degrees F.
Age: 1.03
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Haemoglobin, Seizure
Clinical narrative: 1945 pt began crying and seizing in crib. Seized  2-3 min. Mom called 911, pt transported to ER via ambulance. ER administered TYLENOL and amoxicillin (suspected ear infection). D/C from ER approximately 2200 same night. Temperature on arrival to ER: 103.7 degrees F.
Age: 1.27
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Rash generalised, Rash papular
Clinical narrative: Papular rash all over body, low grade temp.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration, Urticaria
Clinical narrative: Patient behind on immunizations, always got them one at a time. In an attempt to catch up, 3 given at one time and patient developed urticaria.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 1.5 inch below inject site - (R) arm with 4 inch diameter erythema with firmness and tenderness, raised. Occasional numbness to (R) hand thumb and 2nd digit. Onset 2 days post vaccination. Tx for cellulitis as preventative.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Fatigue, Malaise, Nausea, Oropharyngeal pain
Clinical narrative: Received HPV-9 approximately 10am at school based health center without incident. Finished school day and attended volleyball that afternoon. Mother report she came home tired and not feeling well. Next day attended school but that night had chills, nausea and vomited x 1. Fever to 102.4 degrees on 9/4/15 morning. Also with body aches and mild sore throat. 9/5 - some fever. Symptoms resolved by Sunday 9/6/15. Treated with TYLENOL and MOTRIN MOC concerned all reaction to the immunization and was reported. Denies problems with 2 previous HPV 4 vaccinations.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Received HPV-9 approximately 10am at school based health center without incident. Finished school day and attended volleyball that afternoon. Mother report she came home tired and not feeling well. Next day attended school but that night had chills, nausea and vomited x 1. Fever to 102.4 degrees on 9/4/15 morning. Also with body aches and mild sore throat. 9/5 - some fever. Symptoms resolved by Sunday 9/6/15. Treated with TYLENOL and MOTRIN MOC concerned all reaction to the immunization and was reported. Denies problems with 2 previous HPV 4 vaccinations.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Red rash.
Age: 1.0
Sex: U
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates between 01-SEP-2015 and 09-SEP-2015, the patients were vaccinated with MMR II (lot # J013131 and expiration date 17-OCT-2015, lot# J013431 and expiration date 24-OCT-2015, lot# K024825 and expiration date 02-DEC-2016) (dose and route were not reported) that were improperly stored. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates between 01-SEP-2015 and 09-SEP-2015, the patients were vaccinated with ROTATEQ (lot # K019370 and expiration date 16-JUL-2016, lot# K023537 and expiration date 22-JUN-2016, lot# L004466 and expiration date 02-AUG-2016) (dose and route were not reported) that were improperly stored. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant, refers to an unspecified number of patient of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot numbers K014833, expiration date: 14-SEP-2016 and K024036, expiration date 26-NOV-2016, (administration routes were not provided). No concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received form a Medical Assistant, refers to an unspecified number of patient of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # K007264, expiration date: 02-MAR-2017, (administration routes were not provided). No concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant, refers to an unspecified number of patient of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses PNEUMOVAX 23 lot # K007826, expiration date: 03-FEB-2016. No concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant, refers to an unspecified number of patient of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # K021935, expiration date: 10-NOV-2016 and L007226, expiration date: 03-MAR-2014, (administration routes were not provided). No concomitant therapies were reported This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The healthcare worker noted that on unspecified dates, the patients were administered improperly stored PNEUMOVAX 23 injection (dose, route, lot number and expiration date were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unspecified date, since 20-AUG-2015, the patients were vaccinated with an unspecified number of improperly stored doses of PROQUAD (Merck), (dose, frequency and route of administration were not provided), lot # L013545, expiration date 17-OCT-2016. No concomitant medication was reported. At the time of this report, no adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unspecified date, since 20-AUG-2015, the patients were vaccinated with an unspecified number of improperly stored doses of VARIVAX, (dose, frequency and route of administration were not provided), lot # reported as L015049, expiration date 29-APR-2017. No concomitant medication was reported. At the time of this report no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Contusion, Injection site pain, Pain, Rash, Skin warm
Clinical narrative: 9/9 - Patient developed a penny sized bruise the evening of vaccination. It was described as sore and had shooting pain. 9/10 - bruise became rash like, warm, and symptoms persisted. Grew to the size of a half-dollar coin. 9/11 - at the time of reporting, the rash was rectangular in shape (approx 1"x2.5"), warm to the touch. Patient reports shooting pain of 4-5 and not able to sleep on the side of arm where shot was given. Patient denies pain or soreness at the site of Prevnar 13 injection (RA, deltoid). Some soreness was reported for LA deltoid from flu shot, patient has hx of soreness with flu shot).
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Sleep disorder
Clinical narrative: 9/9 - Patient developed a penny sized bruise the evening of vaccination. It was described as sore and had shooting pain. 9/10 - bruise became rash like, warm, and symptoms persisted. Grew to the size of a half-dollar coin. 9/11 - at the time of reporting, the rash was rectangular in shape (approx 1"x2.5"), warm to the touch. Patient reports shooting pain of 4-5 and not able to sleep on the side of arm where shot was given. Patient denies pain or soreness at the site of Prevnar 13 injection (RA, deltoid). Some soreness was reported for LA deltoid from flu shot, patient has hx of soreness with flu shot).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Angioedema, Hypersensitivity
Clinical narrative: Slow onset of allergic reaction including angioedema.  Was treated in the ER on 8/16/2015 for allergic reaction including Epinephrine, Prednisone, Pepcid with continued oral prednisone following discharge.  ER physician and followup with primary care physician suspect allergic reacting to the meningitis vaccination.  Patient received both TDAP and MCV4 vaccine.
Age: 56.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Severe soreness, pain, aching, stiffness, lack of range of motion in shoulder, neck and upper portion of arm above injection site.
Age: 23.0
Sex: F
Vaccine: ANTH, FLU3
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: Swelling, skin is hot to touch, painful. Swelling is spreading as the day  progressed.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Arthralgia, Chills, Computerised tomogram normal, Fatigue
Clinical narrative: Adverse reaction started with joint stiffness for several days, then started to included joint/body aches on/about Aug 8, continued with fatique, slight headache/stomach ache w/ nausea (stiffness and body aches). Aug 12 left work midday with chills and fatigue. Took a nap and took temperature. Temp = 100.6. All symptoms, except fever, continued with slight improvement into Aug 14-15. Most symptoms minimal by Aug 16. Late, 9:30PM on Aug 16, intense headache with mild nausea started. Could not sleep well and no OTC NSAISD or Tylenol had any impact over the next 24 hrs. Could not work.  Notified PC on Aug 18, still not able to work. Ofc visit with PC on Aug 18. Recommended CT Scan which was take at 3pm. Initial read was clear. RX given (TORADOL 60 mg injection, IMITREX 6mg injection) and observation for 30 min then discharged with greatly reduced pain level. From 7-8 to 3 on 1:10 scale. Rx IMITREX 25mg tab, no more than 2 in 24 hrs. IMITREX moderately effective but next day Aug 19, headache continued at a level of about 3. When RX wore off headache returned to about a 5 level. Reported to PC on the evening of Aug 18. PC scheduled Ofc Visit with neurologist.  Ofc Visit with neurologist, Aug 19. CT scan reviewed again and looked clear. Neurological exam completed with no indications of underlying condition. Conclusion provided was ongoing response to MMR vaccine given lengthy immune system reaction from Aug 6-14. Rx given IMITREX 50 mg tab, no more than 4 in 24 hrs. Better relief provided for 2 days. By Aug 22 or so IMITREX did not seem effective in eliminating head ache.  OTCs continued to not be effective. Headache continued (non stop since Aug 16) but with varying levels ranging from 1-3 on 1:10 scale. Attempted homeopathic approach and started taking Hylands Migraine on Aug 25. Seems most effective in keeping headache level low and is able to reduce a level of 3+ back to a 1-2 if 4 hour dosing is inadvertently extended, typically during the night if I don't get up between 2-4AM. Awoke today at 5AM with level 3-4, highest in a week, and could not get back to sleep for over an hour. I suspect the Hylands taken at 5:15 helped.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Impaired work ability, Joint stiffness, Nausea, Neurological examination normal
Clinical narrative: Adverse reaction started with joint stiffness for several days, then started to included joint/body aches on/about Aug 8, continued with fatique, slight headache/stomach ache w/ nausea (stiffness and body aches). Aug 12 left work midday with chills and fatigue. Took a nap and took temperature. Temp = 100.6. All symptoms, except fever, continued with slight improvement into Aug 14-15. Most symptoms minimal by Aug 16. Late, 9:30PM on Aug 16, intense headache with mild nausea started. Could not sleep well and no OTC NSAISD or Tylenol had any impact over the next 24 hrs. Could not work.  Notified PC on Aug 18, still not able to work. Ofc visit with PC on Aug 18. Recommended CT Scan which was take at 3pm. Initial read was clear. RX given (TORADOL 60 mg injection, IMITREX 6mg injection) and observation for 30 min then discharged with greatly reduced pain level. From 7-8 to 3 on 1:10 scale. Rx IMITREX 25mg tab, no more than 2 in 24 hrs. IMITREX moderately effective but next day Aug 19, headache continued at a level of about 3. When RX wore off headache returned to about a 5 level. Reported to PC on the evening of Aug 18. PC scheduled Ofc Visit with neurologist.  Ofc Visit with neurologist, Aug 19. CT scan reviewed again and looked clear. Neurological exam completed with no indications of underlying condition. Conclusion provided was ongoing response to MMR vaccine given lengthy immune system reaction from Aug 6-14. Rx given IMITREX 50 mg tab, no more than 4 in 24 hrs. Better relief provided for 2 days. By Aug 22 or so IMITREX did not seem effective in eliminating head ache.  OTCs continued to not be effective. Headache continued (non stop since Aug 16) but with varying levels ranging from 1-3 on 1:10 scale. Attempted homeopathic approach and started taking Hylands Migraine on Aug 25. Seems most effective in keeping headache level low and is able to reduce a level of 3+ back to a 1-2 if 4 hour dosing is inadvertently extended, typically during the night if I don't get up between 2-4AM. Awoke today at 5AM with level 3-4, highest in a week, and could not get back to sleep for over an hour. I suspect the Hylands taken at 5:15 helped.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Poor quality sleep, Pyrexia
Clinical narrative: Adverse reaction started with joint stiffness for several days, then started to included joint/body aches on/about Aug 8, continued with fatique, slight headache/stomach ache w/ nausea (stiffness and body aches). Aug 12 left work midday with chills and fatigue. Took a nap and took temperature. Temp = 100.6. All symptoms, except fever, continued with slight improvement into Aug 14-15. Most symptoms minimal by Aug 16. Late, 9:30PM on Aug 16, intense headache with mild nausea started. Could not sleep well and no OTC NSAISD or Tylenol had any impact over the next 24 hrs. Could not work.  Notified PC on Aug 18, still not able to work. Ofc visit with PC on Aug 18. Recommended CT Scan which was take at 3pm. Initial read was clear. RX given (TORADOL 60 mg injection, IMITREX 6mg injection) and observation for 30 min then discharged with greatly reduced pain level. From 7-8 to 3 on 1:10 scale. Rx IMITREX 25mg tab, no more than 2 in 24 hrs. IMITREX moderately effective but next day Aug 19, headache continued at a level of about 3. When RX wore off headache returned to about a 5 level. Reported to PC on the evening of Aug 18. PC scheduled Ofc Visit with neurologist.  Ofc Visit with neurologist, Aug 19. CT scan reviewed again and looked clear. Neurological exam completed with no indications of underlying condition. Conclusion provided was ongoing response to MMR vaccine given lengthy immune system reaction from Aug 6-14. Rx given IMITREX 50 mg tab, no more than 4 in 24 hrs. Better relief provided for 2 days. By Aug 22 or so IMITREX did not seem effective in eliminating head ache.  OTCs continued to not be effective. Headache continued (non stop since Aug 16) but with varying levels ranging from 1-3 on 1:10 scale. Attempted homeopathic approach and started taking Hylands Migraine on Aug 25. Seems most effective in keeping headache level low and is able to reduce a level of 3+ back to a 1-2 if 4 hour dosing is inadvertently extended, typically during the night if I don't get up between 2-4AM. Awoke today at 5AM with level 3-4, highest in a week, and could not get back to sleep for over an hour. I suspect the Hylands taken at 5:15 helped.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Soreness at site of injection; redness; raised rash; hot to touch; itching.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Large (>4in,) red, raised, hot rash at injection site.
Age: 60.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness/tingling in arm and fingers.
Age: 60.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Paraesthesia
Clinical narrative: Numbness/tingling in arm and fingers.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: NONE.
Age: 50.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site joint pain, Injection site pain, Pain in extremity
Clinical narrative: Burning pain at injection site and down arm with greatest pain at top of elbow joint. It gets worse with exertion.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, pain and warm on injection site - left arm.