chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 09-OCT-2015, the patient was vaccinated with a dose of VAIRVAX (Merck) (lot # L019130, expiration date 27-MAY-2017, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of 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: Information has been received from a registered nurse referring to a patient of unknown age and gender. Patients current conditions, medical history and concomitant medications was not provided. On 14-OCT-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # L019130, expiration date 27-MAY-2017, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of 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: Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 10-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # K021935, expiration date 10-NOV-2016, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of 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: Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 12-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # K021935, expiration date 10-NOV-2016, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Pain
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient's concurrent condition, medical history, concomitant medication and drug allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, expiry date, dose, units and route were not specified). The illness of patient/sibling at the time of vaccination was not reported. On an unknown date the patient reported that she had pain in the front and back of her body, and at the injection site (specific area unspecified), she also explained that the pain had become very sensitive at the injection site. The outcome of events was unknown at the reporting time. No product quality complaint (PQC) was filed. Causality assessment was not provided. Additional information is not expected as no reporter details were provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse referring to multiple unspecified patients of unknown genders and ages. The patient's medical history and concurrent conditions were not provided. On an unknown date in November 2015, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) lot # L033692, expiration date 28-FEB-2017, (route, anatomical place and dose number were not provided). Concomitant therapies were not provided. At the time of the report, no adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 17-AUG-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K021935, expiration date 10-NOV-2016, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of 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: Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 25-SEP-2015, the patient was vaccinated with a doses of (Oka/Merck) VARIVAX (lot # L019130, expiration date 27-MAY-2017, dose and route were unknown) that was improperly stored. It was reported that the dose were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of 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: Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 06-NOV-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L019130, expiration date 27-MAY-2017, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of 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: Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 29-SEP-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L019130, expiration date 27-MAY-2017, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Injection site pain
Clinical narrative: Information has been received from a physician via a company representative referring to a female patient of unknown age. No pertinent or historical conditions were reported. On an unknown date the patient was vaccinated with GARDASIL 9, one shot/three dose series (strength and route unknown). There was no concomitant medication reported. On an unknown date, the patient experienced injection site pain and some dizziness while on therapy with GARDASIL 9. The adverse experiences had resolved on an unknown date and the patient was fine and would continue the series. Causality between events and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored oral, ROTATEQ (lot # K016263, expiration date 26-JUN-2016; dose not reported). No adverse effect was reported. This one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 24-AUG-2016, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of 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 pharmacy technician referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 08-OCT-2015, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB injection (dose, route and frequency were not provided). Product quality complaint (PQC) was not involved. It was unknown if the patient sought medical attention. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Diahrrea, dark green stool, made bottom raw. Nothing has helped with this since.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Tenderness
Clinical narrative: Immediate pain at time of injection, pain no better a month later; pain in shoulder, especially at injection sight, when using arm. Also pain when laying on side of painful arm (left). I have intense pain when doing things like taking things on/off over my head, using arm to twist off jar lids, any kind of movement that uses the shoulder or puts pressure on the shoulder.
Age: 1.65
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema
Clinical narrative: He woke up with a red mark on his leg which continued to get bigger I took him to the doctors office on Dec 3rd they said keep an eye on it.  It is still increasing in size and I am taking him back for possible cellulitis today.
Age: 1.25
Sex: M
Vaccine: DTAPH, FLUX
Symptoms: Eye movement disorder, Febrile convulsion, Flushing, Lethargy, Muscle twitching
Clinical narrative: Sudden fever 107.0 degrees Fahrenheit axillary, flushed, pale, lethargic, eyes rolled back, legs twitching for 30 seconds. Temperature rechecked after febrile seizure like episode with a result of 102.7 degrees Fahrenheit. Tylenol was given at time of vaccination (3 PM) and at 7 PM after fever. Tylenol and Ibuprofen was alternated for the next 24 hours. Last fever at 11 AM on 11/21/2015. These events occurred after scheduled vaccinations PVC13 and DTAP (previously received) and flu shot (new).
Age: 1.25
Sex: M
Vaccine: DTAPH, FLUX
Symptoms: Pallor, Pyrexia
Clinical narrative: Sudden fever 107.0 degrees Fahrenheit axillary, flushed, pale, lethargic, eyes rolled back, legs twitching for 30 seconds. Temperature rechecked after febrile seizure like episode with a result of 102.7 degrees Fahrenheit. Tylenol was given at time of vaccination (3 PM) and at 7 PM after fever. Tylenol and Ibuprofen was alternated for the next 24 hours. Last fever at 11 AM on 11/21/2015. These events occurred after scheduled vaccinations PVC13 and DTAP (previously received) and flu shot (new).
Age: 1.24
Sex: F
Vaccine: HEP, MMR, PNC13
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: On 10/27/15, 16 month old F was brought to clinic for well child check. During visit, pt received immnizations for hepatitis B, MMR and varicella combined and pneumococcal conjugate vaccine 13-valent. Immunizations were administered without incident and pt was dischaged in stable conditoin. On 10/28, pt's mother called clinic and reported that after injections, pt developed a fever to 102 degrees and diarrhea. LPN advised that these were labeled possible side effects. MD notified and documented "It is possible that this infant is developing early symptoms of varicella, as she has been exposed. Recommend supportive care, patient may see us or her regular pediatrician if worsening or persistent concerns." Event reported to VAERS.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: Rash started at injection site about 30 minutes to one hour after administration and gradually spread over a course of several weeks from back to front. Patient went to physician on 12/2/15 for treatment and received a steroid shot.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort, Pruritus, Rash
Clinical narrative: Patient reported a developing rash overnight, with some discomfort in arm, itching.  Patient had self-treated with ibuprofen and was instructed to try diphenhydramine PO and watch for worsening or continuing symptoms.  If no relief, to seek medical attention for treatment of allergic reaction.  Patient returned later in afternoon with hydroxyzine & prednisone Rx.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 25-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L019130, expiration date 27-MAY-2017, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report refers to a consumer concerning a 62 year old female patient as other company letter. Concurrent condition included: heart disease (RA). On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot # L014876, expiry: 13-JAN-2017) in the right arm. On an unknown date the patient experienced cellulitis in the right arm. The outcome of cellulitis was unknown. Causality assessment was not reported. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal distension, Abdominal pain upper, Balance disorder, Diarrhoea, Gait disturbance
Clinical narrative: Diarrhea until about 3:00 AM, stumbling walk, felt off balance.  Had sore stomach entire next day and felt bloated.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Erythema, Local reaction, Nodule
Clinical narrative: Pt had 2 cm red knot on right thigh, local reaction.  No fever.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: Soreness and limited arm movement.  Exercising.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse referring to multiple unspecified patients of unknown genders and ages. The patient's medical history and concurrent conditions were not provided. On an unknown date in November 2015, the patients were vaccinated with an improperly stored doses of (Oka/Merck) VARIVAX lot # L025207, expiration date 07-JUL-2017, and lot # L020004, expiration date 02-JUN-2017, (route, anatomical place and dose number were not provided), indicated for prophylaxis. Concomitant therapies were not provided. At the time of the report, no effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Contusion, Drooling, Erythema, Local swelling, Pyrexia
Clinical narrative: Fever (12 hours). Drooling (12 hours). Localized brusing. Localised raised, red margins (present). Treatment = BENADRYL.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse referring to multiple unspecified patients of unknown genders and ages. The patient's medical history and concurrent conditions were not provided. On an unknown date in November 2015, the patients were vaccinated with an improperly stored doses of VAQTA, lot L002717, expiration date 02-JUN-2017 and Lot # K018181, expiration date 04-JUN-2017, (route, anatomical place and dose number were not provided). Concomitant therapies were not provided. At the time of the report, no adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 39-year-old female patient who received FLUARIX QUADRIVALENT (batch number HZ723, expiry date 30th June 2016). On 9th October 2015, the patient received the 1st dose of FLUARIX QUADRIVALENT .5 ml. On 10th October 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain and injected limb mobility decreased. The patient was treated with MOTRIN. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. The reporter considered the injection site pain and injected limb mobility decreased to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The patient experienced injection site pain and was not able to lift her arm beginning the day after the vaccination. The pain was persisting almost 2 months later at the time of reporting. The patient was taking MOTRIN to treat the pain. The reporter was wondering if any other events of this type had been reported for this lot of vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. The pharmacist stated that on an unspecified date the patient was administered a partial dose of ZOSTAVAX due to a syringe malfunction. No adverse effect was reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein increased, Fatigue, Headache, Injection site pain, Rash
Clinical narrative: Severe fatigue, debilitating headache, rash. severe face swelling, soreness at injection site, extremely high CRP (96.5) blood test symptoms came slowly over 3 days - 4 dr. visits.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Severe fatigue, debilitating headache, rash. severe face swelling, soreness at injection site, extremely high CRP (96.5) blood test symptoms came slowly over 3 days - 4 dr. visits.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased, Rotator cuff syndrome
Clinical narrative: After receiving injection had normal soreness to right upper arm. Soreness has advanced to limited range of motion with movement and constant pain to upper shoulder. Swelling right upper arm.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Administration site pain, Pain in extremity
Clinical narrative: Patient complains of pain at administration site and all the way down arm.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Limb swelling.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a 68 year old female consumer reporting on herself. Pertinent medical history and concurrent conditions were unspecified by reporter. On 17-NOV-2015, the patient was vaccinated with PNEUMOVAX23 injection, intramuscular for prevention of pneumococcal disease (dose, lot number and expiration date were not reported). Concomitant medications were unspecified by reporter. On 18-NOV-2015, while the patient visiting her physician, the physician, the physician noticed a (softball) sized red mark at the injection site that was also so warm to the touch. The patient stated that she also was suffering stomach aches since receiving the injection. Patient sought medical attention as she saw the provider. Treatment with PREDNISONE was received as physician stated that it should help with redness. The patient stated that after the first dose she noticed decrease in the size of the redness in her arm. At the time of report, it was reported that the patient status was recovering. Additional information is not expected as there was no contact details provided.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown demographics. On 16-FEB-2015, the patient received the second dose of MMR II. The nurse reported that on 16-NOV-2015, the patient was inadvertently administered a third dose of MMR II. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema multiforme, Myalgia
Clinical narrative: Myalgia and erythema multiforme.  Cephalexin mg BID.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: This spontaneous report was received from a physician regarding a 22-year-old female patient. Patient had no pertinent medical history, no drug reactions or allergies and was not on any concomitant therapy. On an unspecified date, prior to receiving vaccines, the patient underwent an unspecified HPV test that came back negative. On an unspecified date in February 2015, the patient was vaccinated with unidentified Merck HPV vaccine (either GARDASIL or GARDASIL 9 or another Merck vaccine). The patient completed the series of vaccination in May 2015. On 27-OCT-2015, the patient underwent an unspecified HPV test and that came back positive. Outcome of the positive HPV test was not known. Causality assessment was not provided. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician via a field representative referring to a 14 year old male patient. Information about medical history, concurrent condition and concomitant medication was not reported. On 27-OCT-2015 the patient was vaccinated with GARDASIL 9 (lot # L016429 with unspecified expiration date, one dose/three dose series; strength and dosage unspecified) for HPV prevention. Concomitant medication included unspecified flu vaccination. On the same day, the patient passed out after administration of vaccination but prior to exiting the office. The parent of the patient informed the physician that the patient did not have much to eat and was nervous prior to the administration of the vaccine. The patient recovered while in the office on the same ay and was able to attend school the following day. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Regurgitation
Clinical narrative: This spontaneous report as received from a physician refers to a 2 month old patient of an unknown gender. The patient's concurrent conditions and medical history were not reported. On 01-DEC-2015, the patient was vaccinated with first dose of ROTATEQ, orally (unknown strength and dose). On 01-DEC-2015 (today), a 2 month old patient was given first dose of oral, ROTATEQ and almost immediately the patient regurgitated the vaccine after it was given. The outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Tremor
Clinical narrative: Patient experienced severe chills/shaking approximately 5 hours after the vaccine in 2014.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 81 year old female patient reporting on herself with none drug reaction or allergies. Patient's pertinent medical history included high blood pressure. In July 2011, the patient was vaccinated once, with a dose of ZOSTAVAX subcutaneous (Lot number, expiration date and dose were not provided) for shingles. Concomitant therapies included lovastatin (manufacturer unknown), diltiazem and KLONOPIN. The patient was diagnosed with herpes zoster reported as "shingles" on 28-NOV-2015. The same day, the patient went to an unspecified urgent care facility and was treated with VALACICLOVIR. On 30-NOV-2015, the patient saw the provider, who was the physician. No laboratory diagnostic studies were performed. The outcome of herpes zoster was reported as recovering. The reporter did not assess the relatedness of ZOSTAVAX to herpes zoster. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria
Clinical narrative: Hivrs around injection site.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, FLUN4
Symptoms: Respiratory symptom, Wheezing
Clinical narrative: Pt given FLU-MIST 10-1-15. When he returned for booster 4 wks later patient and siblings and dad*so it is probably not a vaccine reaction had upper resp symptoms. On exam patient had wheezing; he had not even wheezed before.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Received flu vaccine in left deltoid. Within 30 min. vaccination site became reddened, warm to the touch. No hives or difficulty breathing. Area on arm continued to worsen in the next 48 hours. Referred to urgent care. Pt. received prednisone 50 mg x 5 days.
Age: 1.28
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Drooling, Eye movement disorder, Pyrexia, Seizure, Tremor
Clinical narrative: Received vaccines at 15 mo. Check up 11/30/15 by afternoon of 12/1/15, patient noted to have fever with seizure activity. Described as shaking of arms, legs, eyes rolling to back of head and drooling.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised
Clinical narrative: Full body rash within 48 hours had to take prednisone for 3 days and hydrocortisone topical - went to walk in Urgent Care facility. This is the first time this happened.
Age: 47.0
Sex: U
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Employee received vaccine in left arm, two days later he had a lot of pain, swelling and was unable to lift arm above shoulder level.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: ZOSTAVAX administered on 11-10-15 at pharmacy. Few days later - non-specific bumps on both thighs. No pain, not fluid-filled. Last wk noted zoster-like rash on (L) lower abdomen; groups of bumps on lower back and left hip, left lower abdomen and inguinal area.
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Basedow's disease, Hyperthyroidism
Clinical narrative: I developed Graves disease after the second dose and a hyperactive thyroid.
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Small scattered Rash on body. Low grade temp 99.6. Resolved 3 days Calamine/BENADRYL.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Large 1 1/2 inch red, hard circle at injection site with warmth and itching started day 2 after injection, lasted 5 days - no treatment.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: (L) arm swelling, pain, warmth- treated with KEFLEX for cellulitis.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hypoacusis, Visual impairment
Clinical narrative: After immunization, less than 5 minutes: light headed and dizzy, visual disturbance - bright, hearing muffled.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Electrocardiogram normal, Feeding disorder, Impaired driving ability, Laboratory test normal
Clinical narrative: Rec'd shot 9/3/15 630 became dizzy, nausea, couldn't eat dinner. 9/11/15 dizzy and nausea unable to drive lasted 4 hrs 9/12/15 severe dizzy, nausea, vomiting needed ambulance to Emer Rm. Lasted 5 hrs. 9/22 dizzy 9/23 dizzy 9/27 dizzy - lasted 3 1/2 hrs 9/28 MRI - normal (brain) 10/13 dizzy 10/18 dizzy.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Nuclear magnetic resonance imaging brain normal, Vomiting
Clinical narrative: Rec'd shot 9/3/15 630 became dizzy, nausea, couldn't eat dinner. 9/11/15 dizzy and nausea unable to drive lasted 4 hrs 9/12/15 severe dizzy, nausea, vomiting needed ambulance to Emer Rm. Lasted 5 hrs. 9/22 dizzy 9/23 dizzy 9/27 dizzy - lasted 3 1/2 hrs 9/28 MRI - normal (brain) 10/13 dizzy 10/18 dizzy.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Pt developed pain, rash, fever evening of immuniz. rash progressed covering top arm and around tricep area, pt had fever...treated w/ antihist, compresses, much better, but still hurts as of 12-4-15.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: Pt given DTaP RT IM, Hib in LT IM about 3 hrs later brought child back to office with hives on legs and arms. Gave 12.5 mg/0.25 ml BENADRYL IM and sent child to ER.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Lip swelling, Rash, Urticaria
Clinical narrative: Within 2 min of vaccine administration, broke out in hives on face - no wheezing - oximetry 99 - gave BENADRYL - no progression of hives - consulted allergist by phone who recommended holding off on EPIPEN JR since rash only on face. Monitored for 90 min in office. Total clearing of rash and lip swelling. Will f/u w/ allergist next week.
Age: 1.04
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Ultrasound scan
Clinical narrative: (L) high red and tender 2.75 cm area of redness on ant. (L) thigh, deeper 1 cm nodule.
Age: 1.67
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting multiple times throughout evening and night on 12/3/15 and on the morning of 12/4/15. Explosive diarrhea morning of 12/4/15.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Peripheral swelling, Pyrexia
Clinical narrative: SWELLING AT INJECTION SITE SPREADING TO WRIST AND HAND.  LOW GRADE FEVER PAINFUL AREA.  PRESCRIBED TWO (2) ANTIBACTERIALS. CEPHALEXIN 500MG & SMZ/TMP DS 800-160MG FOR 10 DAYS.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Pt complained of flu-like symptoms including low grade fever, chills, aches and pains for several weeks.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Swelling
Clinical narrative: Pt noted redness and swelling difficulty lifting arm, still with slightly reddened area on inner aspect of (L) arm.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Scab
Clinical narrative: PATIENT HAD SCAB ON VACCINATED HAND AND SPREAD ALL OVER BACK ON SHOULDER AREA AND SPREAD TO OTHER HAND AND ON FACE BROKE OUT INTO SHINGLE RASH AND PATIENT SUFFERING FROM ONE YEAR SHOWED UP AT THE PHARMACY AFTER ONE YEAR AND SYMPTOMS ERUPTED WITHIN A WEEK BUT PATIENT NOT REPORTED
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Computerised tomogram abnormal, Electroencephalogram normal, Hypoxia, Influenza virus test negative, Intensive care
Clinical narrative: Acute respiratory infection, hypoxia, respiratory distress. Possible seizure activity. Normal EEG. Respiratory support provided, oxygen and transfer to PICU x 36 hours.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Respiratory distress, Respiratory syncytial virus test negative, Respiratory tract infection
Clinical narrative: Acute respiratory infection, hypoxia, respiratory distress. Possible seizure activity. Normal EEG. Respiratory support provided, oxygen and transfer to PICU x 36 hours.
Age: 39.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash. Diphenhydramine 25 mg PRN.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Local reaction
Clinical narrative: LOCALIZED REACTION, INDURATED, 3CM DIAMETER. NO SIGNS OF ANAPHYLAXIS NOTED.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Sore Arm ever since shot was given, no redness or swelling.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Headache, Pain, Peripheral swelling
Clinical narrative: Received shingles vaccine on 11/27/15.  Arm became swollen and red on 11/29/15- large egg shaped swollen area about 5 inches w/mottled skin. Experienced low grade fever, body aches and headache on 11/29 and 11/30/15.  By Tuesday, Dec 1 there was one large fluid filled blister surrounded by a red, sore, tender area of five inches. Redness, itchiness and mottled skin continued through Friday, Dec 4, 2015.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Skin discolouration, Tenderness
Clinical narrative: Received shingles vaccine on 11/27/15.  Arm became swollen and red on 11/29/15- large egg shaped swollen area about 5 inches w/mottled skin. Experienced low grade fever, body aches and headache on 11/29 and 11/30/15.  By Tuesday, Dec 1 there was one large fluid filled blister surrounded by a red, sore, tender area of five inches. Redness, itchiness and mottled skin continued through Friday, Dec 4, 2015.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: ARM SORENESS AND PAIN.
Age: 1.09
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Electroencephalogram normal, Febrile convulsion
Clinical narrative: The patient received the pneumococcal vaccine on 7/23/2015. The day after, the patient presented to the ER with febrile seizures.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm where injection was given, swollen and warm and tender to touch, pt seen in office 12/04/15 by MD, no s/s of cellulitis. Motrin/Benadryl and ice as needed. To follow up if worsens or no improvement in 48 hrs.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored GARDASIL 9 (lot # L000610, expiration date 31-JAN-2017; dose and route not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Rotator cuff syndrome
Clinical narrative: Rotator cuff front muscle injury.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient notice big bump on deltoid at injection site, felt pain and itch (warm feeling).
Age: 32.0
Sex: F
Vaccine: YF
Symptoms: Chills, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Calls 12/4/15 at 10:40 AM. Says on evening of vaccination, experienced chills, feverish on through Saturday 11/28/15 where 5am says symptoms eased up. Calls today and says she has rash (light) on left neck and Rt neck has "swollen gland". Recommended to client that she see her primary doctor for eval.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Myalgia, Swelling
Clinical narrative: Myalgia and swelling.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Communication disorder, Laboratory test, Loss of consciousness, Mobility decreased
Clinical narrative: LOSS OF CONSCIOUSNESS FOR 18 HOURS. HOSPITALIZED FOR LACK OF ABILITY TO COMMUNICATE AND MOVE.
Age: 0.12
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever and fussy.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Loss of consciousness, Pallor, Tremor
Clinical narrative: Client sitting in chair for immunization, saw blood with injection. Immediately turned white and complained of a severe headache. Lost consciousness in the chair had tremors of extremities. client lowered to the floor. She regained consciousness within 2 minutes. Able to drink water and eat crackers. Parent with child soon after and stated child has passed out before. Mother gave child Mountain Dew and took her out of the clinic after 15 minute wait.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Crying, Eye pruritus, Headache, Pruritus
Clinical narrative: Uncontrollable crying, stomach pain, head ache, itchy face and eyes, red blotches on face. No fever.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Rash macular
Clinical narrative: Uncontrollable crying, stomach pain, head ache, itchy face and eyes, red blotches on face. No fever.
Age: 72.0
Sex: M
Vaccine: FLUC3
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Severe headache, nausea, slight fever.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Abdominal pain, Acute disseminated encephalomyelitis, Asthenia, Back pain
Clinical narrative: Abdominal pain, back pain, lethargy, extreme weakness, no appetite, fevers, tremor in hands, inability to stand or walk. Patient was hospitalized 3 times so far since this vaccine was administered.  Endless tests have shown little except continuous elevated WBC, sed rate and CRP blood past 6 weeks, MRI of brain and spine showed white matter lesions consistent with ADEM and possible transverse myelitis.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: C-reactive protein increased, Decreased appetite, Dysstasia, Lethargy, Lumbar puncture
Clinical narrative: Abdominal pain, back pain, lethargy, extreme weakness, no appetite, fevers, tremor in hands, inability to stand or walk. Patient was hospitalized 3 times so far since this vaccine was administered.  Endless tests have shown little except continuous elevated WBC, sed rate and CRP blood past 6 weeks, MRI of brain and spine showed white matter lesions consistent with ADEM and possible transverse myelitis.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Pyrexia, Red blood cell sedimentation rate increased, Tremor
Clinical narrative: Abdominal pain, back pain, lethargy, extreme weakness, no appetite, fevers, tremor in hands, inability to stand or walk. Patient was hospitalized 3 times so far since this vaccine was administered.  Endless tests have shown little except continuous elevated WBC, sed rate and CRP blood past 6 weeks, MRI of brain and spine showed white matter lesions consistent with ADEM and possible transverse myelitis.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: White blood cell count increased, White matter lesion
Clinical narrative: Abdominal pain, back pain, lethargy, extreme weakness, no appetite, fevers, tremor in hands, inability to stand or walk. Patient was hospitalized 3 times so far since this vaccine was administered.  Endless tests have shown little except continuous elevated WBC, sed rate and CRP blood past 6 weeks, MRI of brain and spine showed white matter lesions consistent with ADEM and possible transverse myelitis.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Face injury, Fall, Haematoma, Loss of consciousness
Clinical narrative: After receiving Gardasil, pt on bedside table. Nurse Sat to document injection and patient fell from bedside table to floor face first. LOC 30 seconds. Large lemon size hematoma middle of forehead. Pt oriented to place and person. Mom at side. MD called to bedside. VSS. See flowsheet. Ambulance called and pt transported via ambulance to ED.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Tremendous pain and limited arm mobility.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain in the arm, aching pain, difficulty moving the arm.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Dyspnoea, Feeling of body temperature change, Inappropriate schedule of drug administration, Mobility decreased
Clinical narrative: Patient received 7th Anthrax booster on 13 Aug 2014 at around 10am. Patient complained that at 10pm that night he had hot and cold flashes, chills, felt feverish, difficulty breathing and moving. Patient said symptoms began to dissipate at around 5am the next day. Patient did not go to the E.R. ergo no treatment was made. Patient is overdue for next booster but is concerned due to prior reaction. Provider unsure to exempt the patient due to no documentation of treatment or reaction until now.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Patient received 7th Anthrax booster on 13 Aug 2014 at around 10am. Patient complained that at 10pm that night he had hot and cold flashes, chills, felt feverish, difficulty breathing and moving. Patient said symptoms began to dissipate at around 5am the next day. Patient did not go to the E.R. ergo no treatment was made. Patient is overdue for next booster but is concerned due to prior reaction. Provider unsure to exempt the patient due to no documentation of treatment or reaction until now.
Age: 0.45
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain, Eye movement disorder, Full blood count, Metabolic function test, Respiratory arrest
Clinical narrative: Shaking, eyes rolled back, (lasted aprox 5-10min) not breathing. Was rushed by POV to ER.
Age: 0.45
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Tremor, Viral upper respiratory tract infection
Clinical narrative: Shaking, eyes rolled back, (lasted aprox 5-10min) not breathing. Was rushed by POV to ER.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus generalised
Clinical narrative: Arm sore for 1 week. Redness, swelling from hand to bicep. Itchiness all over body.
Age: 26.0
Sex: M
Vaccine: DTAP
Symptoms: Diarrhoea, Disturbance in attention, Ear swelling, Erythema, Local swelling
Clinical narrative: Swelling in face, neck, ears. Extremely ill feeling. Rash all over. Redness in skin. Skin extremely itchy. Diarrhea stools. Blurred vision. Trouble concentrating.
Age: 26.0
Sex: M
Vaccine: DTAP
Symptoms: Malaise, Pruritus, Rash generalised, Swelling face, Vision blurred
Clinical narrative: Swelling in face, neck, ears. Extremely ill feeling. Rash all over. Redness in skin. Skin extremely itchy. Diarrhea stools. Blurred vision. Trouble concentrating.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Patient vomited once at 8:30 PM.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Vaccine administered to Left Deltoid 12/1/15. 12/2/15 injection site felt sore to patient. 12/3/15 patient noticed area was now red and warm, but did not hurt or itch. 12/4/15 patient presented to pharmacy and the above was seen by pharmacists. patient states they have an appointment with their doctor to address it.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Injection site pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Patient started having aching pain where flu shot was given starting 2 hours after vaccination. As the day went on the pain worsened. Pain spread to whole shoulder, arm pit, whole arm, and up to the neck. Patient has had constant pain since.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Head discomfort, Headache
Clinical narrative: Unusual searing headache. Feeling of pressure on brain. Feeling of pressure persistent as of 12/04/2015. Ibuprofen helps but interval between relief is becoming shorter.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Pyrexia, Tremor
Clinical narrative: This spontaneous report was received from a nurse concerning a 54 year old male patient. The patient's pertinent medical history included stage III cancer which currently was in remission. The patient's historical drugs included PREVNAR 13 received on 02-SEP-2015. On 30-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K019561 Expiration date: not reported) (dose, route and anatomical location of administration were not reported). Concomitant therapies included NEURONTIN and TOPOMAX. On 30-NOV-2015, reported as "immediately following", the PNEUMOVAX 23 vaccination, the patient developed tremors in both of his upper arms and a slight fever. On the same day, the patient's vital signs were taken and his temperature was 99.8 F, pulse was 118 (units not provided), respiratory rate was 20 (units not provided), and blood pressure was 135/77 (units not provided), "everything else was fine". Later, the patient's vital signs were checked again on the same evening and his temperature was 99.1 F, pulse was 89 (units not provided), respiratory rate was 20 (units not provided), and blood pressure was 97/60 (units not provided). Also, the patient was no longer experiencing tremors. No treatment was given for the adverse events and no Product Quality Complaint (PQC) was involved. The outcome of tremor and pyrexia was reported as recovered on 30-NOV-2015. The reporting nurse considered the tremor and pyrexia as a temporarily significant disability. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Middle insomnia, Tremor
Clinical narrative: Shot itself was painless. Within a few hours of injection, left shoulder started to hurt. Couldn't lift arm above 50 degree angle. 14 days later because of pain, still can't lift arm beyond 50 degrees. Hand and arm shakes when lifted above 50 degrees, awakens at night because of pain.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Over the period of 12 hours, client had symptoms of increase pain, swelling of arm from shoulder to elbow of left arm, limited mobility following vaccination. On day 2 following vaccination, client received treatment per MD, diagnosed with cellulitis.
Age: 13.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Given VARIVAX and Hep B (ENGERIX-B) vaccines at office during wellness check. Waited in office 15 min after injection. No problems noted. Mom called office back shortly after leaving and stated that patient was itching and had hives. No SOB, etc. Advised to give BENADRYL and come back to office for monitoring. Monitored in office x30-45 min. No further symptoms. Home on BENADRYL.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Patient developed chills and fever in the evening after getting a shot. He went to urgent care to verify if he is developing flu. Ultimately fever was contained by TYLENOL.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: On Monday 11-30-15 pt received Tdap vaccine on right arm. On Tuesday 12-1-15 pt noticed right upper arm swelling, soreness and redness, and warm to touch. Pt came to walk-in clinic to see doctor. Prescribed antibiotics and was told to use cool compresses to (R) arm.