chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuritis, Pain, Rash vesicular
Clinical narrative: Information had been received on 12-SEP-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 22-JAN-2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 06-SEP-2016, patient was treated for herpetic neuritis and prescribed valacyclovir by a physician. On or about 16-NOV-2016, patient was treated by physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles accompanied by post-herpetic neuritis. Patient has been prescribed VALTREX, LYRICA, gabapentin, NEURONTIN and lidocaine cream for management of her painful symptoms and herpetic complications. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information was received on 12-SEP-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 21-MAY-2012 at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 27-JUL-2016, the patient was treated by a LPN for a painful outbreak that was diagnosed as herpes zoster, or shingles. On or about 30-JUL-2016, the patient was treated again for continued and worsening symptoms of shingles outbreaks and intense pain. The patient has been prescribed VALTREX for management of her painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information was received on 12-SEP-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 17-OCT-2013 at a medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 26-AUG-2016, the patient was treated at the medical center for a painful outbreak that was diagnosed as herpes zoster, or shingles. On or about 04-SEP-2016, the patient was treated again for continued and worsening symptoms of shingles outbreaks. The patient has been prescribed VALTREX for management of his painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients received doses of improperly stored ZOSTAVAX vials of 19400 Plaque-Forming Units (PFU), lot # N009167 with expiration date on 02-FEB-2018 (doses and routes of administration were not reported). The nurse confirmed that the sterile diluent (manufacturer unknown) (unspecified lot # and expiration date) used to reconstitute the ZOSTAVAX was properly stored. Administered doses of vaccines underwent a temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit, which lasted for 65 hours. There was no previous temperature excursion. A digital data logger was not involved in recording the excursion. No adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 25-year-old male patient  with history of seizure. The patient's concurrent conditions included tobacco abuse and cannabis abuse. The patient had no concomitant therapies and no drug reactions or allergies. On 12-SEP-2017, the patient was vaccinated with "1 dose" of GARDASIL 9 lot number N007931 with expiration date 17-NOV-2019 (dose number, route and anatomical location were not reported) for human papillomavirus (HPV) prevention. On the same date about 15 minutes after vaccination with GARDASIL 9 while the patient was still in the office, he had a Grand-Mal seizure (generalised tonic-clonic seizure). The nurse practitioner called the emergency medical service (EMS) and the patient was took to the hospital as treatment for the event. At the time of the report, the outcome of the generalised tonic-clonic seizure was unknown. The relatedness between the event and therapy with GARDASIL 9 was not reported. The reporter considered the generalised tonic-clonic seizure to be serious as possible life threatening event. Upon internal review, generalised tonic-clonic seizure was determined to be medically significant event.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant therapies were not reported. On an unknown date, the patient might have vaccinated with an improperly stored dose of VARIVAX (dose not reported) lot # L043620 (expiration date 02-NOV-2017) for prophylaxis. According to the reporter, the dose of VARIVAX was exposed to the following temperature excursion: -14 Celsius (C) degrees to -10 C (time frame: 6 hours and 15 minutes). A digital data logger was involved. No adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # N012131 expiration date 17-APR-2019 (dose and route of administration were not reported). The vaccines were reconstituted with sterile diluents (manufacturer unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 6 degrees Fahrenheit and 17 degrees Fahrenheit for 3 hours and 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUX, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 07-SEP-2017, the patient was vaccinated with an improperly stored dose VARIVAX lot # N014632 with expiration date on 11-MAY-2019 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine experienced temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 9 hours. There were no previous temperature excursions. Digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA004806.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a rheumatologist via other company (Pfizer) (manufacturer report number: 2017336899) on 05-SEP-2017. This case involves a 63-year-old female patient who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medication were not reported. On 01-AUG-2017, following vaccination, it was reported that patient developed allergy to tetanus. Lab tests and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Flatulence, Gait disturbance, Poor quality sleep
Clinical narrative: Initial unsolicited report received from a consumer (patient's ex-wife) on 06-Sep-2017. This case involves an 81 year male patient (age also reported as 82 year) who was vaccinated with a dose of FLUZONE HD (Batch number, expiry date, dose, dose in series and site and route of administration were not reported) on 04-Sep-2017 in afternoon. Patient's medical history was reported that pre-existing physician diagnosed allergies, birth defect, medical condition included Diabetes, Hypertension, Hypercholesterolemia, had no known allergies. Illness at the time of vaccination was none. Any other vaccinations within four weeks of vaccinations were none. On 04-Sep-2017 evening, few hours following the vaccination, the patient became very dizzy, and he needed to hold on to the walls to walk. On 05-Sep-2017, one day following vaccination patient was a little dizzy in the morning, and was very gassy all day. 06-Sep-2017, two days following vaccination he was very tired, and he didn't sleep very well. Patient also stated he was not dizzy today. Reporter stated patient was planning on seeing his doctor today. Laboratory investigations were none and corrective treatment were not reported. The outcome of event was reported as unknown. List of documents held by sender: none.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Patient called the pharmacy on 9/15/17 around 10 am. She stated she was concerned because she was still having pain, swelling, and heat at the injection site. She told me she had a large red whelp that was swollen from the injection site to her elbow. The area itched, was painful, radiated heat, and was about the size of her hand. I told the patient to take 2 Benadryl 25mg pills and call her primary care doctor. I told her if her symptoms got worse to call 911 or go to the emergency room if able. She agreed and the conversation ended. I called her back at 12:15 pm to check on her. She told me that she had taken the Benadryl after we talked, but could not reach her doctor. I asked if there was any change in her condition. She stated there was some improvement. The area was not as hot and had decreased in size to about the size of her palm. I told her I was glad she was doing better and that I would call her in another few hours. I also left a messsage with the nurse and am waiting for a call back.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: Patient called the pharmacy on 9/15/17 around 10 am. She stated she was concerned because she was still having pain, swelling, and heat at the injection site. She told me she had a large red whelp that was swollen from the injection site to her elbow. The area itched, was painful, radiated heat, and was about the size of her hand. I told the patient to take 2 Benadryl 25mg pills and call her primary care doctor. I told her if her symptoms got worse to call 911 or go to the emergency room if able. She agreed and the conversation ended. I called her back at 12:15 pm to check on her. She told me that she had taken the Benadryl after we talked, but could not reach her doctor. I asked if there was any change in her condition. She stated there was some improvement. The area was not as hot and had decreased in size to about the size of her palm. I told her I was glad she was doing better and that I would call her in another few hours. I also left a messsage with the nurse and am waiting for a call back.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site bruising, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Had fever like symptom 2 hours after shot, nausea, throat burning, chills which subsided the next morning. Redness and swelling at site of injection happened 2 hrs after. Bruising at site occurred later that night.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Throat irritation
Clinical narrative: Had fever like symptom 2 hours after shot, nausea, throat burning, chills which subsided the next morning. Redness and swelling at site of injection happened 2 hrs after. Bruising at site occurred later that night.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Pt started having a sore leg hours after the injections. And over the course of the next few days it started to get worse, she was complaining about itching on the wound, the area was hot, to the touch, bright red, and bruising in the center of the effected area. The top half of her thigh was swollen, and the was a hard knot over the area. I took her back to the Dr and they looked her over, and I was told to get her benadryl, and Tylenol.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt started having a sore leg hours after the injections. And over the course of the next few days it started to get worse, she was complaining about itching on the wound, the area was hot, to the touch, bright red, and bruising in the center of the effected area. The top half of her thigh was swollen, and the was a hard knot over the area. I took her back to the Dr and they looked her over, and I was told to get her benadryl, and Tylenol.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed cellulitis around injection site.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Diarrhoea, Injection site erythema, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, fever, redness at site of reaction. Patient went to doctor who prescribed ZOFRAN.
Age: 1.83
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Gastrointestinal tube insertion, Nuclear magnetic resonance imaging, Paralysis, X-ray
Clinical narrative: Paralyzed from throat down, had to have feeding tube.
Age: 30.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Syncope
Clinical narrative: Patient left the vaccine area and about 5 min later fainted at the store entrance area. No signs before shots were given. Patient mentioned after fainting she had no food in her today and only 2 cups of coffee.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chills, Fatigue, Impaired work ability, Malaise, Pain
Clinical narrative: Patient said 30 minutes after vaccine administration he experienced fever, chills, achiness, tiredness, and has been sick for several days and has had to call off work.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pyrexia
Clinical narrative: Patient said 30 minutes after vaccine administration he experienced fever, chills, achiness, tiredness, and has been sick for several days and has had to call off work.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: Patient said 30 minutes after vaccine administration he experienced fever, chills, achiness, tiredness, and has been sick for several days and has had to call off work.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Myalgia, Nasal congestion, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient said 30 minutes after vaccine administration he experienced fever, chills, achiness, tiredness, and has been sick for several days and has had to call off work.
Age: 48.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Rhinorrhoea
Clinical narrative: Patient said 30 minutes after vaccine administration he experienced fever, chills, achiness, tiredness, and has been sick for several days and has had to call off work.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diet refusal, Irritability, Neurological examination normal, Tongue movement disturbance
Clinical narrative: 2 days after getting immunizations patient refused to eat, tongue thrusting, he was fussy after immunizations but then 2 days refusing to drink, no changes in formula, not vomiting but had one mucus stool. We brought him in for evaluation at day 4 after the immunizations (9/15/17).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Left arm swelling, redness, warmth , pain and itching. Treatment BENADRYL, warm compresses and antibiotic for possible secondary infection.
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a medical assistant referring to a female patient of unknown age. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. In 1999, the patient was vaccinated with PEDVAXHIB (dose, route of administration and lot number were not reported) for prophylaxis. Other suspect therapies included (unspecified), DTaP (manufacturer not reported) and poliovirus vaccine inactivated (unspecified) (manufacturer not reported). The medical assistant reported that the patient received a "vaccine combination, DTaP, Polio and some kind of HIB back in 1999 where the combination caused hives". The outcome of hives was resolved/recovered. Causality assessment was not provided by the reporter. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination
Clinical narrative: This spontaneous report was received from a pharmacist and referred to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX (lot # and expiration date were not reported). The ZOSTAVAX was reconstituted with sterile diluent (manufacturer unknown). The pharmacist stated that the patient was taking valacyclovir hydrochloride (dose, frequency, route of administration, indication, lot # and expiration date were not reported) at the time, the patient was vaccinated with ZOSTAVAX.
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Injection site pain
Clinical narrative: This spontaneous report was received from a female patient unknown age who was also a physician, referring to herself. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 23-AUG-2017, the patient was vaccinated with her second dose hepatitis a vaccine, inactivated (manufacturer unknown) intramuscular (strength, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 23-AUG-2017, the patient developed severe pain at the injection site and felt weak and had been experiencing these adverse events since she received the hepatitis a vaccine, inactivated (manufacturer unknown). Despite of this, the patient had not look for medical attention or received any treatment for the aforementioned adverse events. The outcome of severe pain at the injection site and felt weak was not recovered. The reporter did not mention or establish any causal relationship between the aforementioned adverse events and hepatitis a vaccine, inactivated (manufacturer unknown).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or pertinent medical histories provided. On unknown dates, the patients were vaccinated with improperly stored PROQUAD lot # M044719, expiration date 07-MAY-2018 and lot# N014634, expiration date 07-NOV-2018. Concomitant therapies included properly stored sterile diluent. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of -14 to - 10 degrees Celsius for 562 hours 16 minutes. There were previous temperature excursion. Digital data logger was involved. The outcome of incorrect product storage was unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA008035.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 26 year old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-SEP-2017, the patient was vaccinated with ZOSTAVAX 19400 Plaque-Forming Units (PFU), 1 dose, lot # N003697, expiration date 13-MAR-2018 (route of administration was not reported) instead of the scheduled one dose of VARIVAX. Concomitant therapies included sterile diluent. No adverse effects were reported. The outcome of wrong drug administered was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse prescriber via a Company representative referring to an 87 year old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2010, the patient was vaccinated with ZOSTAVAX (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. On 13-SEP-2017, the patient was diagnosed with shingles. The patient was seen by a nurse practitioner and received an unspecified treatment for herpes zoster. No laboratory diagnostics were performed. No intervention to prevent serious criteria was necessary and herpes zoster was not significant disability or incapacity or life threatening. The patient was not hospitalized. No product quality complaint was involved. At the time of the report, the outcome of herpes zoster was reported as not recovered. The relatedness assessment between ZOSTAVAX and herpes zoster was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or pertinent medical histories provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX lot# N014630, expiration date 11-MAY-2019 (dose and route of administration were not reported). Concomitant therapies included properly stored sterile diluent. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of -14 to - 10 degrees Celsius for 562 hours 16 minutes. There were previous temperature excursion. Digital data logger was involved. The outcome of incorrect product storage was unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA006159.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity, Skin warm
Clinical narrative: The evening of the vaccination arm became slightly sore. When awakened next morning, L arm was extremely sore and warm to the touch. Then second day post vaccination, awakened to redness at two areas on L arm distal to injection site is 3x2.5"  red area, warm to touch and very sore. Another site above injection site 2x2" area is right above axillary area is lightly red but very sore.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Next day presented with redness and swelling of the entire arm (not just localized to the injection site). Developed fever >99 degrees F as well as chills and body aches. Symptoms resolved after approximately 48 hours.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Next day presented with redness and swelling of the entire arm (not just localized to the injection site). Developed fever >99 degrees F as well as chills and body aches. Symptoms resolved after approximately 48 hours.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Right arm pain day of the immunization characterized by "extreme muscle pain" when "reaching or lifting ". Scale 0-10, 0 = no pain, pain can be up to a "6".
Age: 57.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: TDAP- given left arm - not sure what vaccine it was - was given at work place. Hep B- given right arm no adverse reactions. Swelling, redness, baseball size bump, - very painful....could barely lift arm -  the day after 9/6/17 had chills, painful, body aches, like a truck ran me over..... 10 days later I still have a dime size bump at injection site. Went to primary care at work clinic - she marked it...to make sure redness didn't get any bigger....and told to put ice on it.
Age: 57.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pain
Clinical narrative: TDAP- given left arm - not sure what vaccine it was - was given at work place. Hep B- given right arm no adverse reactions. Swelling, redness, baseball size bump, - very painful....could barely lift arm -  the day after 9/6/17 had chills, painful, body aches, like a truck ran me over..... 10 days later I still have a dime size bump at injection site. Went to primary care at work clinic - she marked it...to make sure redness didn't get any bigger....and told to put ice on it.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: The client came back to the vaccination site and notified PHN about the adverse reactions. PHN observed hives developed on face and neck to chest. No other adverse reactions reported or observed. Diphenhydramine 25 mg x2 pills (PO) given to the client. PHN reassessed the client 30 minutes later. The symptoms resolved and the client stabilized. PHN followed up with the client in the following day. The client reported no recurrent hives. PHN advised her to take BENADRYL 50 mg two more times within 48 hours from the event.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Eye movement disorder, Lethargy, Postictal state, Seizure like phenomena, Tremor
Clinical narrative: Mom reports that the patient had a vaccine (PEDIARIX) on her right side and later that day 7/31/17, they went home and she began shaking on the left side. She also had rapid eye movement. The event went on for several seconds and then stopped. Pt was lethargic after the event and recovered quickly.   The next day mom reports that she had another event similar to the first one, but she had full body shaking which looked like a seizure. Rapid eye movement and mom says she had seen a seizure before and this went on for about 20 seconds and stopped. Again the patient was postictal (lethargic)  she recovered quickly. Mom did not report fever. Mom reported this to our office during the next visit ( four month well child visit).
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling hot, Pruritus generalised, Rash macular
Clinical narrative: Pt received flu vaccine at approximately 11:30 am on 9/12/2017. At 2:00 pm on 9/12/17, pt reports itching all over with no rash, shortness of breath, or difficulty swallowing. Pt sent to Emergency Dept. Pt given prescription for Prednisone 20 mg and recommended to take Benadryl, Claritin, or Zyrtec as needed for itching. Pt reports red blotches on face, continued itching, and feeling hot all over that evening. Pt took Allegra (without D) and Prednisone on 9/13/2017. Pt was seen 9/14/2017 at Occupational Health Services to report lessening itching and blotches are clearing. Physician's Assistant told pt to continue Prednisone and Allegra.
Age: 47.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Chills, Dizziness, Hyperhidrosis, Impaired work ability, Injection site erythema
Clinical narrative: I became ill with chills and then severe sweating that evening after receiving them. Also had extreme pain, hot and red itching on my shoulder where one of the vaccines went in. The following day I was still not feeling very well and by the third day I was dizzy, felt faint and sweating. I was so bad the third day, I had to go home after being at work a short time.
Age: 47.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Malaise
Clinical narrative: I became ill with chills and then severe sweating that evening after receiving them. Also had extreme pain, hot and red itching on my shoulder where one of the vaccines went in. The following day I was still not feeling very well and by the third day I was dizzy, felt faint and sweating. I was so bad the third day, I had to go home after being at work a short time.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Anthrus reaction not at injection site.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Pain in left arm characterized when used and at rest. Decreased shoulder mobility. Radiates to left outer chest wall.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration
Clinical narrative: Local redness and induration, started on antihistamines, no lip/tongue/throat swelling nor respiratory symptoms.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Urticaria
Clinical narrative: Pt received flu shot and left clinic. He returned approximately 25 mins later to report hives on neck and headache but breathing ok. Pharmacist had stepped out for a few minutes. Pt just wanted to report incident and left. We contacted him 10-15 mins later and pt reported symptoms had improved and we recommended BENADRYL . Pt said he had some and would take at home.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Muscle swelling, Rash, Skin warm
Clinical narrative: Red, warm, swollen deltoid muscle, rash spreading down toward elbow.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: See other notes Mom was instructed to have child go to an allergy DR.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dysstasia, Feeling hot, Hyperhidrosis, Hypotension, Palpitations
Clinical narrative: Patient got really hot and started sweating and claimed her heart was racing. She then had trouble standing up and slid to the floor. Both of these happened about 5-10 minutes after the immunizations. EMT showed up and said she had a low blood pressure and then they were going to do an EKG on the ambulance since the daughter did say that she had heart issues.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Hypersensitivity, Rash, Rash erythematous
Clinical narrative: Vaccines administered around 12:30 PM approximately 3-5 minutes after administration of vaccines an erythematous raised patches diffusely on face was noted. BENADRYL was administered at 12:38 PM. Rash resolved on face. Patient was observed for 30 minutes after vaccines given. Lungs clear to auscultation b/l after allergic reaction noted and prior to leaving office. Spoke with maternal grandmother at 3:19 PM patient doing well and no allergic reaction or respiratory symptoms.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis (red swollen hot to touch itching upper left arm). Right arm did not have any issues.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: 9/7/17 C/O ONE INCH REDDENED AREA, RIGHT DELTOID @ SITE OF MENINGOCOCCAL IMM.  NO C/O PAIN, OR ITCHING. PT. /MOTHER INSTRUCTED TO USE COLD COMPRESSES, AND IF NO RELIEF, TO RETURN TO CLINIC FOR PROVIDER TO ASSESS. CALL TO MOTHER, AREA RESOLVED  9/9/17.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient started with a warm arm well below the injection site with redness some time on 9/14/17. She went to the walk in clinic on 9/15/17 and the Provider there diagnosed her with cellulitis "probably" from the vaccination. She was prescribed prednisone and BACTRIM DS and the red area was "circled" by the provider.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: The patient began to break out with a rash starting on her back approximately 1 hour after being vaccinated. This spread around her waist and up to her trunk. The rash subsided approximately 3 to 4 days later. The patient used cetirizine on her own to treat the rash and did not seek out further medical care. Of note, all materials used including gloves and bandages were latex free.
Sex: U
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician referring to an unspecified patient of "less than 2 years of age" and unknown gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date, the patient was inadvertently vaccinated by mistake with RECOMBIVAX HB, (dose, route of administration and lot # were not reported) for prophylaxis instead of a dose of VAQTA. It was unknown if the patient had received any previous doses of RECOMBIVAX HB or what caused the medication error. No further information was provided. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received on 28-AUG-2017 from a nurse who was reporting on a 63 year old male patient. No concomitant medications or medical history was reported. On 18-AUG-2017, the patient received a dose of VARIVAX (lot N001530, expires 13-JAN-2019) 0.5 ml subcutaneously (injection site not reported), instead of a dose of ZOSTAVAX. Lot number and expiration of sterile diluent was not reported. No adverse effects reported. The nurse stated that she thought that their pharmacy had reported the event to VAERS (no number available). No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse and refers to multiple unspecified patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD lot # N004629 and expiration date of 07-AUG-2018, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (lot # unknown). The vaccine was stored in unspecified temperature range and time frame. Previous temperature excursion was reported as unspecified. No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Sender's Comments: US-009507513-1709USA007420.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse and refers to multiple unspecified patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX lot # N012618 and expiration date of 21-APR-2019, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (lot # unknown). The vaccine was stored in an unspecified temperature range and time frame. Previous temperature excursion was reported as unspecified. No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Sender's Comments: US-009507513-1709USA007318.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Malaise, Tremor
Clinical narrative: Chills "shaking like a leaf", feeling of unwell. Started in the early morning around 1:30am. Feels very tired. No fever. Chills are now gone.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Redness and swelling at injection site and extensively involving lower arm over the period of several days worsening after injections.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Hyperhidrosis, Nocturia, Tremor
Clinical narrative: PATIENT REPORTED SWEATS, ACHING JOINTS, SHAKING AND HAD TO GO TO THE RESTROOM MULTIPLES DURING THE NIGHT.
Age: 18.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MENB, MMR, VARCEL
Symptoms: Eye movement disorder, Loss of consciousness, Nausea, Pallor, Seizure like phenomena
Clinical narrative: Patient was administered vaccines listed above at approx. 3:40pm. Right arm was done last with the HPV being the last vaccine given. After administering HPV, the patient's eyes started rolling in his head and his skin color went pale. The patient then began having seizure like activity and the nurse lowered him to the ground and called for more help. EMS was called. The patient passed out as he was being lowered to the floor. No injuries were sustained at this time. Patient came back to consciousness and felt nauseas. Ice packs were placed on patients' forehead and neck. Patient was given juice and vitals were taken @ 3:48pm. Vitals were stable. EMS arrived on scene and at that time patient was conscious and said that he felt okay. Parent declined child to go with EMS for further evaluation.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh, from knee to hip, red and swollen one hour or less after injection. No difficulty walking spreading to other parts of the body, no other reaction. Symptoms resolved by 9/12/17.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient reported severe pain at site of PREVNAR injection (right arm) and limited mobility in that arm.  She was concerned about possible injury in that arm due to previous rotator cuff surgery and tendon injury in that arm. Pharmacist advised her to ice it and take a pain reliever. The next morning, patient came to pharmacy and said she had a little more mobility but the injection site was still very painful and the pain radiated down her arm. She said she had iced  the area all night long. She had the arm in a sling. Pharmacist checked the site and did not see any redness or swelling at this time. Patient requested a report to be filed regarding this reaction. If pain/mobility does not improve, patient will contact physician.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site reaction, Skin reaction
Clinical narrative: Patient came in 2 days later on 9/15/17 with a prescription from ER for Doxycycline 100mg. Patient stated she had skin reaction to the vaccination she was given two days ago and and went to Emergency room. Patient was given antibiotic for cellulitis to be treated for 7 days. Her arm had erythema around the upper arm area.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: LUE: warmth/swelling/pain, increasing in size.
Age: 56.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Asthenia, Chest discomfort, Gait disturbance, Muscle spasms, Pyrexia
Clinical narrative: As per patient report right after he received the vaccinations he felt discomfort in his chest area. He had trouble walking. And later on he had muscle spasms, weakness, fever. He went to see the doctor and he was given antibiotics which he came to pick up today 9/15/17.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Pain in arm radiating to fingers.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Abdominal pain, Anger, Blood test, Cognitive disorder, Culture throat
Clinical narrative: Sudden fits of rage: unprovoked screaming (never happened before); grabbing head/rocking and blood curdling screaming. Spends a lot more time alone. Decreased eye contact. His skin erupted in the worst "eczema" ever within 1 day of the shot. Fever. Inability to listen/follow directions (He used to be able to follow 5 commands in order without us having to repeat any steps). He developed a sore throat, loss of appetite, diarrhea and abdominal pain (also there was a white nodule in his throat).
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Culture urine, Decreased appetite, Decreased eye contact, Diarrhoea, Differential white blood cell count
Clinical narrative: Sudden fits of rage: unprovoked screaming (never happened before); grabbing head/rocking and blood curdling screaming. Spends a lot more time alone. Decreased eye contact. His skin erupted in the worst "eczema" ever within 1 day of the shot. Fever. Inability to listen/follow directions (He used to be able to follow 5 commands in order without us having to repeat any steps). He developed a sore throat, loss of appetite, diarrhea and abdominal pain (also there was a white nodule in his throat).
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Dyskinesia, Eczema, Full blood count, Headache, Metabolic function test
Clinical narrative: Sudden fits of rage: unprovoked screaming (never happened before); grabbing head/rocking and blood curdling screaming. Spends a lot more time alone. Decreased eye contact. His skin erupted in the worst "eczema" ever within 1 day of the shot. Fever. Inability to listen/follow directions (He used to be able to follow 5 commands in order without us having to repeat any steps). He developed a sore throat, loss of appetite, diarrhea and abdominal pain (also there was a white nodule in his throat).
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Mononucleosis heterophile test, Nodule, Oropharyngeal pain, Platelet count, Pyrexia
Clinical narrative: Sudden fits of rage: unprovoked screaming (never happened before); grabbing head/rocking and blood curdling screaming. Spends a lot more time alone. Decreased eye contact. His skin erupted in the worst "eczema" ever within 1 day of the shot. Fever. Inability to listen/follow directions (He used to be able to follow 5 commands in order without us having to repeat any steps). He developed a sore throat, loss of appetite, diarrhea and abdominal pain (also there was a white nodule in his throat).
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Screaming, Social avoidant behaviour, Streptococcus test, Toxicologic test, Urine analysis
Clinical narrative: Sudden fits of rage: unprovoked screaming (never happened before); grabbing head/rocking and blood curdling screaming. Spends a lot more time alone. Decreased eye contact. His skin erupted in the worst "eczema" ever within 1 day of the shot. Fever. Inability to listen/follow directions (He used to be able to follow 5 commands in order without us having to repeat any steps). He developed a sore throat, loss of appetite, diarrhea and abdominal pain (also there was a white nodule in his throat).
Age: 75.0
Sex: M
Vaccine: FLUA3
Symptoms: Depressed mood, Tearfulness
Clinical narrative: Sudden onset depressed mood and tearfulness upon awakening two days later.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal growth restriction
Clinical narrative: Miscarriage. Fetus stopped growing 5 days after vaccination, Miscarried 4 weeks later.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Contusion, Myalgia, Nausea, Pyrexia
Clinical narrative: 104 degree fever, extreme joint and muscle pain (whole.body), nausea,  bruising in thighs. No pain in injection are.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Huge rash sore injection site needed prescription cream for relief.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Huge rash sore injection site needed prescription cream for relief.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Decreased appetite, Headache, Malaise, Myalgia, Nausea
Clinical narrative: Client received immunization in the morning and states he started feeling systemic symptoms by the next day. He mentioned symptoms included headaches, muscle aches, malaise, loss of appetite, nausea. States he felt a sore arm the evening after immunizations were administered but that systemic symptoms "hit all at once." Symptoms continued for 2 days and today states he feels better. States symptoms were not those that he usually has felt after vaccinations in the past, but were intense systemic symptoms. Describes as feeling "significantly sick." Client used anti-inflammatory medications for symptoms. Did not visit a provider.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Client received immunization in the morning and states he started feeling systemic symptoms by the next day. He mentioned symptoms included headaches, muscle aches, malaise, loss of appetite, nausea. States he felt a sore arm the evening after immunizations were administered but that systemic symptoms "hit all at once." Symptoms continued for 2 days and today states he feels better. States symptoms were not those that he usually has felt after vaccinations in the past, but were intense systemic symptoms. Describes as feeling "significantly sick." Client used anti-inflammatory medications for symptoms. Did not visit a provider.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Decreased appetite, Headache, Malaise, Myalgia
Clinical narrative: Client received immunization in the morning and states she started feeling systemic symptoms by that evening. She mentioned her symptoms were headaches, elevated temperature of about 100F, muscle aches, malaise, loss of appetite, nausea. States all symptoms "hit all at once." Symptoms continued for 2 days and today she feels better. States symptoms felt worse in the evenings. States symptoms were not those that she usually has felt after vaccinations in the past where she "could go about [her] day," but were intense systemic symptoms. Describes as feeling "significantly sick." Client used anti-inflammatory medications for symptoms. Did not visit a provider.