chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Ultrasound Doppler
Clinical narrative: This spontaneous report was received from a 53 year old female patient and refers to herself. The patient's pertinent medical history included Sjogren's syndrome (an autoimmune disorder) since approximately 2003 (reported as 12  years prior to being administered ZOSTAVAX). The patient had a history of allergic reactions to codeine (unspecified dosage, lot #, expiration date, manufacturer) with onset of hives and "throwing up and passing out briefly" on unknown dates. On an unspecified date in the middle of January 2015, the patient was vaccinated with a dose ("1 shot") of ZOSTAVAX in the unspecified arm (strength, dose, route of administration, lot # and expiration date were not provided). The vaccination was recommended to the patient by a pharmacist. No information regarding the patient's concomitant therapies was reported. On an unspecified date in the middle of January 2015 (reported as since she received ZOSTAVAX, the patient experienced "not feeling well afterwards". On an unspecified date, the patient experienced "redness and arm swelling" at the injection site of ZOSTAVAX with lasted few weeks. The patient did not seek medical attention at this time but took TYLENOL (unspecified dosage, lot #, expiration date and manufacturer) as treatment for the arm swelling. On an unknown date, the patient experienced "chills in her legs and pain in the lower part of her legs". This pain was described as "seeing and feeling the veins popping out of her legs". The patient sought medical attention with three unspecified vascular doctors and one cardiologist on unspecified dates. The patient took NEURONTIN (unspecified dosage, lot #, expiration date and manufacturer) for her leg pain, but it "aggravated the symptoms" and she stopped this medication on an unspecified date. On  unknown dates, two studies were performed: a venous Doppler of her legs and an arterial study. Both studies "only showed normal aging results". On an unknown date, the patient broken her toe (case of this injury was  unknown). The outcome of not feeling well, injection site redness and arm swelling was not reported. The outcome of chills in her legs, pain in the lower part of her legs and broken toe was considered as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Infectious mononucleosis, Mononucleosis heterophile test, Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative regarding a 17 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date the patient completed full series of GARDASIL lot, dosage regimen unknown as injection. Concomitant medications were not reported. On an unknown date the patient was diagnosed with mononucleosis. After post mononucleosis diagnosis several months later, the patient's mother complained to the nurse practitioner that the GARDASIL caused the patient to experience an unspecified rash and fatigue (onset date unknown). The patient did not seek medical attention and no treatment was given for the adverse events. The outcome of events was unknown. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Attention deficit/hyperactivity disorder, Breast mass, Coeliac disease, Constipation
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative regarding a 17 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date the patient completed full series of GARDASIL lot, dosage regimen unknown as injection. Concomitant medications were not reported. On an unknown date the patient was diagnosed with mononucleosis. After post mononucleosis diagnosis several months later, the patient's mother complained to the nurse practitioner that the GARDASIL caused the patient to experience an unspecified rash and fatigue (onset date unknown). The patient did not seek medical attention and no treatment was given for the adverse events. The outcome of events was unknown. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Diarrhoea, Dysuria, Ear tube insertion, Epstein-Barr virus test positive, Fatigue
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative regarding a 17 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date the patient completed full series of GARDASIL lot, dosage regimen unknown as injection. Concomitant medications were not reported. On an unknown date the patient was diagnosed with mononucleosis. After post mononucleosis diagnosis several months later, the patient's mother complained to the nurse practitioner that the GARDASIL caused the patient to experience an unspecified rash and fatigue (onset date unknown). The patient did not seek medical attention and no treatment was given for the adverse events. The outcome of events was unknown. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Full blood count normal, Haemoglobin normal, Headache, Infectious mononucleosis, Mononucleosis syndrome
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative regarding a 17 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date the patient completed full series of GARDASIL lot, dosage regimen unknown as injection. Concomitant medications were not reported. On an unknown date the patient was diagnosed with mononucleosis. After post mononucleosis diagnosis several months later, the patient's mother complained to the nurse practitioner that the GARDASIL caused the patient to experience an unspecified rash and fatigue (onset date unknown). The patient did not seek medical attention and no treatment was given for the adverse events. The outcome of events was unknown. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle twitching, Neurological examination normal, Rash, Rectal haemorrhage, Red blood cell count normal
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative regarding a 17 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date the patient completed full series of GARDASIL lot, dosage regimen unknown as injection. Concomitant medications were not reported. On an unknown date the patient was diagnosed with mononucleosis. After post mononucleosis diagnosis several months later, the patient's mother complained to the nurse practitioner that the GARDASIL caused the patient to experience an unspecified rash and fatigue (onset date unknown). The patient did not seek medical attention and no treatment was given for the adverse events. The outcome of events was unknown. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urine analysis normal, Vertigo, White blood cell count decreased
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative regarding a 17 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date the patient completed full series of GARDASIL lot, dosage regimen unknown as injection. Concomitant medications were not reported. On an unknown date the patient was diagnosed with mononucleosis. After post mononucleosis diagnosis several months later, the patient's mother complained to the nurse practitioner that the GARDASIL caused the patient to experience an unspecified rash and fatigue (onset date unknown). The patient did not seek medical attention and no treatment was given for the adverse events. The outcome of events was unknown. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Treponema test positive
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 16 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patient was vaccinated with her first 2 doses of GARDASIL (exact doses, routes, lot numbers and expiration date were not reported). On an unknown date, the patient received her third dose within the series with GARDASIL 9 (dose, route, lot# and expiration date were not reported). On an unknown date, the patient made a blood donation wand and later tested positive for syphilis. The outcome of syphilis test positive and interchange of vaccine products was not reported. The reporter was concerned that the positive result for syphilis could be linked to the patient's receipt of the GARDASIL and GARDASIL 9. The relatedness between the event interchange of vaccine products and suspect therapies was not reported. Additional information is not expected, as no contact details were provided.
Age: 73.0
Sex: M
Vaccine: RAB
Symptoms: Altered visual depth perception
Clinical narrative: Initial unsolicited report received from a consumer on 16 March 2016. This case involves a 73-year-old male patient who was vaccinated with a series (four doses) of Imovax Rabies from 12 February 2016 to 26 February 2016 and a dose of Imogam (batch number was unknown, route and site of administration was not reported for both vaccines) on an unspecified date at emergency room. The patient had a medical history of cataract Surgery and retinal surgery. The patient had allergies of sulfa medications, numerous food, mold and dust. Patient did not have illness at the time of vaccination. Concomitant medications were not reported. On an unspecified date, three weeks following the vaccination, the patient experienced eye problem for depth perception. The patient visited physician for evaluation and treatment. Lab data corrective treatments were not reported. The patient was not recovered from the event. Upon internal review, the company decided to consider the event serious due to important medical event: Altered visual depth perception. List of documents held by sender: none. Sender's Comments: This is a poorly documented case of eye problem for depth perception after vaccination with RABIES (HDC) VACCINE and PASTEURIZED HUMAN RABIES IMMUNOGLOBULIN. This is not a medically confirmed case. In this particular case patient had a history of cataract surgery and retinal surgery. No further details (indication of surgery), regarding retinal surgery has been provided. It was reported that consumer received the vaccines post exposure, so the rabies status in the animal would be helpful for assessment of the case. Further information regarding medical confirmation of the case, investigation results if any to rule out the alternative etiology are needed for complete assessment of the case. Based on the available information it is not clear whether the reported event is related to patient's medical history or is of neurological origin or vaccine related complication, hence no conclusion can be drawn for now.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to a 5 year old male patient. Concurrent conditions and medical history of the patient were not reported. On 14-SEP-2015, the patient was vaccinated in left thigh with dose of improperly stored (Merck) VARIVAX (dose and route were unspecified) lot # L018001, expiration date: 19-MAY-2017. Concomitant therapies included MMR II vaccinated in right thigh and PEDIARIX vaccinated in right thigh. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to five unspecified patients of unknown age and gender. The patients concurrent conditions, medical history and concomitant medications were not reported. The nurse reported that, on an unspecified dates, the five unspecified patients received improperly stored GARDASIL with lot # K003520 and expiration date 20-NOV-2016, (strength, dose number, dose and route unspecified). GARDASIL was exposed to temperature of - 0.1 degrees C for time frame of 14 hours, in which 5 doses were administered; there was no previous temperature excursion. No adverse effects were reported. Product quality issue (PQC) was not involved. No further information was provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Electromyogram abnormal, Injection site bruising, Injection site erythema, Neuralgia
Clinical narrative: Redness at injection site, bruising. Approx 1-2 week after vaccine had nerve pain in legs, arms. Progressed to weakness and continued pain in bilateral legs, arms.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity, Radiculopathy
Clinical narrative: Redness at injection site, bruising. Approx 1-2 week after vaccine had nerve pain in legs, arms. Progressed to weakness and continued pain in bilateral legs, arms.
Sex: U
Vaccine: MMR
Symptoms: Drug hypersensitivity, Hypersensitivity, Urticaria
Clinical narrative: This spontaneous report was received from a Registered Nurse via company representative referring to a child of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with the first dose of M-M-R II (route, lot number and expiration date were not provided). Concomitant therapies were not provided. On an unknown date, the patient experienced allergic reaction with hives (drug hypersensitivity). The case did not involve cancer or overdose, the patient did not die and there was no intervention to prevent serious criteria. There was no  PQC involved. The outcome of drug hypersensitivity was unknown. The reporter considered drug hypersensitivity to be related to M-M-R II. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Feeling abnormal, Mobility decreased, Pain, Paralysis
Clinical narrative: Next morning felt general aches took ibuprofen. Went bowling and 30 minute walk. Late in afternoon around 5-6 pm did not feel right. All of a sudden couldn't move head to toe. Tried to stay calm because it was frightening to be paralysed. It was 20 minutes before could get up and went to bed. Did not have phone in bedroom to call for help. Felt sleep after a while and woke up around 4 am to go to the bathroom; legs were loose enough by then to go to the bathroom. Went to kitchen and waited until 8:30 am to call doctor; doctor called back 1.5 hours later. Paralysis was starting to leave but couldn't move arms or head. By 3/10, 2 days later, finally movement on arms and head came back -- these were the last 2 parts to get back to normal. Felt back to new by 3/11; recovered completely. Did not go to the doctor at any point. During paralysis episode had chills but not sweaty.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to a 2 year old female patient. Concurrent conditions and medical history of the patient were not reported. On 17-SEP-2015, the patient was vaccinated in right thigh with dose of improperly stored (Merck) VARIVAX (dose and route were unspecified) lot # L018001, expiration date: 19-MAY-2017. Concomitant therapies included MMR II vaccinated in left thigh and PENTACEL in right thigh. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Injection site erythema, Injection site reaction, Lip swelling, Macule
Clinical narrative: 21y/o female presenting after developing rash after smallpox vaccine.  This was pt's 2nd smallpox vaccine (1st in 2000 when pt was abroad; no reaction after that one).  Pt provided pictures of her rash progression.  2 days after her smallpox vaccine, pt has small erythematous macules/papules over her face and chest.  Itchy and pt treated with Benadryl.  Skin completely recovered for 1 week, then pt developed diffuse and progressive erythematous macules to patches over face, chest, back, abdomen, legs.  The lesions were well demarcated, raised, circular, and clumped together.  +Itchy.  Lesions did not wax/wane but worsened to maximal in 2 days, and then took 2 wks to completely resolve.  Pt also had upper lip swelling.  No oral lesions.  Pt was seen in ER and treated with Benadryl which only made her sleepy.  Medrol dosepak helped the most.  Pt also took Zantac, Claritin, and Zyrtec.  Denied any vesicles, crusts, flaking/peeling of lesions.  Erythematous patches resolved without any scarring.  Today pt has faint pink patches over arms of where lesions were.  The smallpox site is crusted over.  Pt's pictures did show her smallpox vaccine site was also large erythematous beyond the bandaid area during the worst part of her reaction.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Papule, Pruritus, Rash, Scab
Clinical narrative: 21y/o female presenting after developing rash after smallpox vaccine.  This was pt's 2nd smallpox vaccine (1st in 2000 when pt was abroad; no reaction after that one).  Pt provided pictures of her rash progression.  2 days after her smallpox vaccine, pt has small erythematous macules/papules over her face and chest.  Itchy and pt treated with Benadryl.  Skin completely recovered for 1 week, then pt developed diffuse and progressive erythematous macules to patches over face, chest, back, abdomen, legs.  The lesions were well demarcated, raised, circular, and clumped together.  +Itchy.  Lesions did not wax/wane but worsened to maximal in 2 days, and then took 2 wks to completely resolve.  Pt also had upper lip swelling.  No oral lesions.  Pt was seen in ER and treated with Benadryl which only made her sleepy.  Medrol dosepak helped the most.  Pt also took Zantac, Claritin, and Zyrtec.  Denied any vesicles, crusts, flaking/peeling of lesions.  Erythematous patches resolved without any scarring.  Today pt has faint pink patches over arms of where lesions were.  The smallpox site is crusted over.  Pt's pictures did show her smallpox vaccine site was also large erythematous beyond the bandaid area during the worst part of her reaction.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: Intussusception.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Noticed "rash" on tops thighs and a patch on the back of left thigh. Denies itching, shortness of breath, or difficulty swallowing.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal distension, Diarrhoea, Local reaction
Clinical narrative: Local reaction, bloating, diarrhea.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Extra dose administered
Clinical narrative: This spontaneous report was received from a pharmacist via company representative, regarding to a patient of unknown age and gender. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot, expiry date, dose, units, route and anatomical location were not reported) at age 40 (inappropriate schedule of drug administration) an again in their 50's. Concomitant medications were not reported. There was no Product Quality Concerns (PQC) involved. No further information was available. Additional information is not expected as no reporter details were provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 22-FEB-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (Lot # K009105, expiration date 21-JAN-2016) 0.5 ml, intramuscular (anatomical location was unspecified). The patient's concomitant medications were not provided. No adverse effects reported. No additional information was provided. No product quality complaint was involved. Additional information is not expected because there is no consent to contact the reporter.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Skin exfoliation
Clinical narrative: This spontaneous report was received from a pharmacist via employee and refers to an elderly patient (age reported as over 65 years old) of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date, exact dose and route of administration were not reported). On an unknown date, the patient experienced injection site pain, injection site peeling of skin, injection site warmth and injection site swelling. No product quality complaint (PQC) was involved. The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with MMR II (dosing details were not reported) either 1 or 2 doses. On an unknown date the patient had titers drawn which showed negative for mumps (antibody test negative). The outcome of the event was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender with no pertinent medical history or unknown drug reactions/allergies. No information regarding the patient's concurrent conditions was provided. On 13-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9. (route of administration, lot# and expiry date were not reported). On 13-OCT-2015, the patient received the second dose of GARDASIL 9 (route of administration, lot# and expiry date were not reported). On 05-MAR-2016, the patient was vaccinated with a dose of GARDASIL injection, lot # L004601, expiry date on 04-NOV-2016 (dose, route of administration were not reported) instead of her third dose of GARDASIL 9 lot # L004601, expiry date on 04-NOV-2016, due to an unspecified reason. Concomitant therapies were not reported. At the time of this report, no adverse effects were reported. No product quality complaint was filled. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 0.87
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Case number PHEH2015US010822, is an initial spontaneous report from a physician received on 04 Jun 2015. This report refers to a 10 months female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with first dose of RABAVERT (batch number: 559011A, expiry date: 28 Apr 2018) on 27 May 2015. On the same day, after vaccination, the patient experienced loose stool for one day. Final outcome of the event was unknown. Seriousness and causality of the event was not reported. The patient was vaccinated with second dose of RABAVERT (batch number: 546011A, expiry date: 30 May 2018) and experienced fever (see case: PHEH2015US011126).
Age: 1.21
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL, FLUX, HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: 101.1 Fever.
Age: 1.26
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient came to MD's office on 3/21/16 and presented with fever and swelling & redness at injection site. Parents stated fever started on 3/20/16.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: Pt received shingles vaccine 3/7/16 and 2 days later developed itch and vesicles L leg and 3/10 developed vesicles L buttock and labia. Pt given Valacyclovir.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex test negative, Oral disorder, Photophobia, Swelling face
Clinical narrative: Patient has a h/o HSV. Received zoster vaccine 2/23/16 and developed multiple presumed herpes lesions on gums along with facial swelling/photophobia on 3/8-3/9. HSV culture of lesion negative.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient experienced redness and swelling on  his arm. Started to run a  fever on 3/16/2016., Felt hot to the touch. Went to Doctor office, and was prescribed an antibiotic.
Age: 72.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Joint stiffness, Pain in jaw
Clinical narrative: Received telephone call at 9A on day following vaccinations. Client reports severe pain in (R) upper arm and difficulty moving arm. Also reported "stiffness" and "numbness" in jaw below (R) ear. Advised to call primary care provider. Telephoned client at 230P on 03-23-16 as f/u. She states she took a nap after call with me on 03/22 and arm pain was gone when she woke up, so she did not call Dr. States jaw discomf. lasted approx. two hrs. outside doing yardwork yesterday.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Right thigh with approximately 2.5 cm area of erythema with induration; no warmth to touch, no tenderness to palpation.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, soreness, pain over about a 48 hour period.  Treated for possible cellulitis.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Bradycardia, Burning sensation, Cardiovascular evaluation, Dry mouth
Clinical narrative: Flush, headache, feeling like on fire and all body was red, couldn't breathe, head to Emergency room.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Flushing, Generalised erythema, Headache, Laboratory test
Clinical narrative: Flush, headache, feeling like on fire and all body was red, couldn't breathe, head to Emergency room.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Lower respiratory tract infection, Muscle spasms, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Flush, headache, feeling like on fire and all body was red, couldn't breathe, head to Emergency room.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling, Tremor
Clinical narrative: Flush, headache, feeling like on fire and all body was red, couldn't breathe, head to Emergency room.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Headache, Hyperhidrosis, Malaise, Pallor
Clinical narrative: At approximately 10:20 (5-7 min post-vaccination) client c/o not feeling well and went to school nurse's office. Client was seen by the school nurse slumped over and seized for approximately 30 sec.  Client then vomited and felt dizzy/lightheaded, diaphoresis was noted. Client was laid on a cot and VS were taken - HR 82, RR 14, Temp 98.7, BP 110/62, 95% on RA. Client was quite pale and stated he had developed a HA (3/10 on pain scale). Client's parent was called and arrived 10-15 post-seizure. Parent stated only medical hx was surgical removal of subarachnoid cyst in July 2014, denied any food/drug allergies or previous reactions to vaccine. Client takes Vyvance qday for ADHD. Parent called pediatrician and neurologist. Both physicians declined to see the client as they felt the client was not in any danger and his reaction was not related to his current or previous medical history. Client's mother took him home after an additional 30-45 min of monitoring by the school nurse.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Seizure, Vomiting
Clinical narrative: At approximately 10:20 (5-7 min post-vaccination) client c/o not feeling well and went to school nurse's office. Client was seen by the school nurse slumped over and seized for approximately 30 sec.  Client then vomited and felt dizzy/lightheaded, diaphoresis was noted. Client was laid on a cot and VS were taken - HR 82, RR 14, Temp 98.7, BP 110/62, 95% on RA. Client was quite pale and stated he had developed a HA (3/10 on pain scale). Client's parent was called and arrived 10-15 post-seizure. Parent stated only medical hx was surgical removal of subarachnoid cyst in July 2014, denied any food/drug allergies or previous reactions to vaccine. Client takes Vyvance qday for ADHD. Parent called pediatrician and neurologist. Both physicians declined to see the client as they felt the client was not in any danger and his reaction was not related to his current or previous medical history. Client's mother took him home after an additional 30-45 min of monitoring by the school nurse.
Age: 1.26
Sex: F
Vaccine: MMR
Symptoms: Cough, Decreased appetite, Pyrexia, Rash
Clinical narrative: Rash, fever 102F, cough, no appetite.  Lasted about 3 days.  Cough and rashes continued to come and go for four months.
Age: 0.5
Sex: F
Vaccine: PNC
Symptoms: Autoimmune disorder, Basedow's disease, Heart rate increased, Hyperthyroidism, Tremor
Clinical narrative: Accelerated heart rate, shaking hands... diagnose as severe hyperthyroidism.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site pain, Pyrexia, Rash erythematous
Clinical narrative: Fever, red rash and sharp shooting pains around injection site, shortness of breath.
Age: 0.09
Sex: M
Vaccine: DTAPHEPBIP, HEP, PER, RVX
Symptoms: Body temperature decreased, Body temperature fluctuation, Influenza, Pallor, Peripheral coldness
Clinical narrative: When we got home son was sleeping for very long time. It was impossible to wake him up. He was absolutely white and very cold. His fever was going from 104 to 95 in minutes. He was shaking. Next day he was sick with severe flu. We took him back to doctor office for a couple of times following week. His temperature was jumping up and down for a couple of days.
Age: 0.09
Sex: M
Vaccine: DTAPHEPBIP, HEP, PER, RVX
Symptoms: Pyrexia, Somnolence, Tremor
Clinical narrative: When we got home son was sleeping for very long time. It was impossible to wake him up. He was absolutely white and very cold. His fever was going from 104 to 95 in minutes. He was shaking. Next day he was sick with severe flu. We took him back to doctor office for a couple of times following week. His temperature was jumping up and down for a couple of days.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Pruritus, Swelling
Clinical narrative: After the injections pt states after 10 mins started to have pain at site.  Day of day 2 pain increasing then 3rd day decreasing pain then increasing itching and pain went down over days 4 through 6 but itching increased day 7 extreme itching all redness width of 3 to 3 and 1/2 inches 2/3 of arm circumference but today the redness is going down and swelling.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Tendonitis, Weight bearing difficulty
Clinical narrative: Pt. states her armpit to elbow was sore.  She states this was still present 6weeks later when she seeked medical attention.  She now has loss of flexibility in that arm and is unable to lift heavy thing.  States that and MRI shows inflammation of tendons.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Autoimmune disorder, Blood test, Computerised tomogram, Dysarthria, Headache
Clinical narrative: My symptoms presented very similarly to a stroke. Slurred speech, impaired motor skills. Facial muscles pulling to the right around mouth. Eventual paralysis of right side that eventually returned mostly with the help of physical and occupational therapy. My right side still has intermittent weakness. My speech still slurs. And I've still had a headache at the base of my skull since the first event.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Hemiparesis, Hemiplegia, Laboratory test, Motor dysfunction, Neurological symptom
Clinical narrative: My symptoms presented very similarly to a stroke. Slurred speech, impaired motor skills. Facial muscles pulling to the right around mouth. Eventual paralysis of right side that eventually returned mostly with the help of physical and occupational therapy. My right side still has intermittent weakness. My speech still slurs. And I've still had a headache at the base of my skull since the first event.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Nuclear magnetic resonance imaging, VIIth nerve paralysis
Clinical narrative: My symptoms presented very similarly to a stroke. Slurred speech, impaired motor skills. Facial muscles pulling to the right around mouth. Eventual paralysis of right side that eventually returned mostly with the help of physical and occupational therapy. My right side still has intermittent weakness. My speech still slurs. And I've still had a headache at the base of my skull since the first event.
Age: 13.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Agitation, Dyskinesia, Erythema, Hunger, Pallor
Clinical narrative: At 1050 patient presented to clinic for immunization accompanied by mother. Nurse performed a pre-screening assessment for vaccine contraindications. Patient and patient's mother reported no history of allergies, seizures, or other medical comorbidities. Patient reported a history of fainting after receiving vaccine and nurse decided to administer the vaccinations while patient is lying down on the bed. At 1100, nurse administered Tdap and VZV on the patient's left arm. After administration, patient complained that she felt hungry, so mother went to get a granola snack. When mother came back into the room, nurse noticed that patient was pale and patient started sliding down the bed. Nurse ensured patient was safe on the bed and could not fall off. Mother then took patient's legs and lifted them. Patient then became agitated, started squirming around and then started to snore loudly. Patient's face turned red and nurse assessed she was still breathing and attempted to wake the patient up. Nurse then immediately called for help from the clinic next door and called to bring the vital machine. Nurse then had patient smell an alcohol pad and patient quickly awoken. 2 other nurses from the other clinic came in and brought the blood pressure machine. BP: 105/65 HR: 65, RR: 16. Patient states she does not remember what happened and said she felt like she "had a dream." Nurse determines that patient's syncopal episode lasted about 1 minute. Patient was given apple juice from the clinic next door and the granola snack from her mother and encouraged to stay in clinic to monitor for 20 minutes. Patient denied any shortness of breath, throat tightening, itching, headaches, pain, or injuries. Patient sustained no injuries and left the clinic in a stable condition. ER precautions given to patient.
Age: 13.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Snoring, Syncope
Clinical narrative: At 1050 patient presented to clinic for immunization accompanied by mother. Nurse performed a pre-screening assessment for vaccine contraindications. Patient and patient's mother reported no history of allergies, seizures, or other medical comorbidities. Patient reported a history of fainting after receiving vaccine and nurse decided to administer the vaccinations while patient is lying down on the bed. At 1100, nurse administered Tdap and VZV on the patient's left arm. After administration, patient complained that she felt hungry, so mother went to get a granola snack. When mother came back into the room, nurse noticed that patient was pale and patient started sliding down the bed. Nurse ensured patient was safe on the bed and could not fall off. Mother then took patient's legs and lifted them. Patient then became agitated, started squirming around and then started to snore loudly. Patient's face turned red and nurse assessed she was still breathing and attempted to wake the patient up. Nurse then immediately called for help from the clinic next door and called to bring the vital machine. Nurse then had patient smell an alcohol pad and patient quickly awoken. 2 other nurses from the other clinic came in and brought the blood pressure machine. BP: 105/65 HR: 65, RR: 16. Patient states she does not remember what happened and said she felt like she "had a dream." Nurse determines that patient's syncopal episode lasted about 1 minute. Patient was given apple juice from the clinic next door and the granola snack from her mother and encouraged to stay in clinic to monitor for 20 minutes. Patient denied any shortness of breath, throat tightening, itching, headaches, pain, or injuries. Patient sustained no injuries and left the clinic in a stable condition. ER precautions given to patient.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: PT PRESENTED TO PHARMACY SAYING THE VACCINE RECEIVED WAS GIVEN IN THE BONE BY PHARMACIST. SHE HAS HAD PAIN IN ARM AND HAS TO GO TO PHYSICAL THERAPY.
Age: 43.0
Sex: F
Vaccine: FLUN4
Symptoms: Back pain, Chest pain, Cough, Dysphonia, Dyspnoea
Clinical narrative: The day after administered FLUMIST, my throat was sore. For a week, my voice was hoarse and coworkers thought I was ill. I had a dry cough. On 10/23, I began experiencing pain in left arm with increased in intensity in evenings, especially while laying flat. On 10/28 I had to constantly inhale as I could not stop yawning. At 3:30, the left arm pain began to gravitate to my back and by 4:30 it had moved to my chest causing shortness of breath. I went to urgent care. I had several indicators for a heart issue and was ambulanced to another hospital where I was promptly diagnosed with Pericarditis. I spent three days and followed treatment plan by doctors with prescriptions. Once off prescriptions, I had an additional Pericarditis event in March 2015 and again recently in February 2016.
Age: 43.0
Sex: F
Vaccine: FLUN4
Symptoms: Laboratory test normal, Oropharyngeal pain, Pain in extremity, Pericarditis, Yawning
Clinical narrative: The day after administered FLUMIST, my throat was sore. For a week, my voice was hoarse and coworkers thought I was ill. I had a dry cough. On 10/23, I began experiencing pain in left arm with increased in intensity in evenings, especially while laying flat. On 10/28 I had to constantly inhale as I could not stop yawning. At 3:30, the left arm pain began to gravitate to my back and by 4:30 it had moved to my chest causing shortness of breath. I went to urgent care. I had several indicators for a heart issue and was ambulanced to another hospital where I was promptly diagnosed with Pericarditis. I spent three days and followed treatment plan by doctors with prescriptions. Once off prescriptions, I had an additional Pericarditis event in March 2015 and again recently in February 2016.
Age: 89.0
Sex: F
Vaccine: TDAP
Symptoms: Deafness unilateral, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, burning, swelling and itching near injection site began after the vaccination was administered and has persisted to present. Days after the vaccine, patient also developed vertigo and loss of hearing in the right ear.
Age: 89.0
Sex: F
Vaccine: TDAP
Symptoms: Vertigo
Clinical narrative: Redness, burning, swelling and itching near injection site began after the vaccination was administered and has persisted to present. Days after the vaccine, patient also developed vertigo and loss of hearing in the right ear.
Age: 20.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Injection site rash, Muscular weakness
Clinical narrative: Rash at injection site after 2 days after vaccine and then 5 wks later, apx 11/21/15 started with thigh weakness, neuro dx'ed as variant Guillain-Barre, resolved March 2016.
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Pain
Clinical narrative: Information has been received from a healthcare worker referring to a 73 year old male patient. The patient did not have any pertinent medical history, drug reactions or allergies. On 23-FEB-2016, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # L018503, expiry date 16-MAR-2017) (dose, route and site of administration were not reported). The patient did not take any concomitant medications. Following that administration the patient experienced swelling at the injection site, and "body aches" all over the body" on 24-FEB-2016. There were no lab diagnostics studies performed. The patient sought medical attention via calling the physician's office. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX23 was not provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Headache, Pain
Clinical narrative: Information has been received from a healthcare worker referring to a 73 year old male patient. The patient did not have any pertinent medical history, drug reactions or allergies. On 23-FEB-2016, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # L018503, expiry date 16-MAR-2017) (dose, route and site of administration were not reported). The patient did not take any concomitant medications. Following that administration the patient experienced swelling at the injection site, and "body aches" all over the body" on 24-FEB-2016. There were no lab diagnostics studies performed. The patient sought medical attention via calling the physician's office. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX23 was not provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker (Medical assistant) concerning multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ 9lot # L027726 with expire date 10-MAY-2017) (dose and dose number not reported) orally. The improper conditions of storage was 9 degree centigrade for 2 hours. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker (Medical assistant) concerning multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L023387 with expire date 22-JUN-2017)(dosage and route not reported). The improper conditions of storage was 9 degree centigrade for 2 hours. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified number of patients. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown date in March 2016 (starting on or after 09-MAR-2016) the patient was vaccinated with improperly stored ZOSTAVAX (lot/batch # L008351, expiry date 11-JUN-2016, lot # L028283, expiry date 28-OCT-2016 (dose, frequency, route and anatomical location were not reported) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Concern (PQC) involved. Temperature at which the administered product was stored as 9.3 Fahrenheit for 20 hours, there were no previous temperature excursions performed. This is one of several reports received from same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified number of patients. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown date in March 2016 (starting on or after 09-MAR-2016), the patients were vaccinated with improperly stored PROQUAD (Merck) lot # K018142, expiry date 10-APR-2016, lot # K024765, expiry date 08-JUN-2016, lot # L030585, expiry date 10-FEB-2017 (dose, frequency, route and anatomical location were not reported) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Concerns (PQC) involved. Temperature at which the administered product was stored was 9.3 Fahrenheit, there were no previous temperature excursions performed. This is one of several reports received from same reporter. Additional information has been requested.