chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: First, red streak at injection site. As time progresses the site turned hard and raised. Painful and itchy grew to 2 inches by 3 inches.  Then on same arm five chicken pox blisters developed. Developed a rash on chest, same side of body as injection. More chicken pox are showing up on my back.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site streaking, Injection site swelling, Rash, Varicella
Clinical narrative: First, red streak at injection site. As time progresses the site turned hard and raised. Painful and itchy grew to 2 inches by 3 inches.  Then on same arm five chicken pox blisters developed. Developed a rash on chest, same side of body as injection. More chicken pox are showing up on my back.
Sex: U
Vaccine: PPV
Symptoms: Malaise, Vaccination failure
Clinical narrative: This solicited report has been received from a 62 year old female patient who is enrolled in a Market Research Program concerning to an unspecified number of people. The patients' concurrent condition, historical conditions and concomitant medications were not reported. On an unknown date, the unspecified patients were vaccinated with doses of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route and anatomical location were not reported). The reporter stated that "many people" she knew were vaccinated and "it made them sick (malaise) and they still had the disease". The outcome of the event was reported as not recovered. The causality between the events malaise and vaccination failure and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was reported as related. Additional information is not expected as the reporter did not consent for further follow up.
Age: 82.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling, Local swelling, Swelling face
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 14-MAY-2016, the patient was vaccinated with a dose of ZOSTAVAX which had a lot # L036822 (expiration date 24-DEC-2016), with a dosage of 0.65 ml, subcutaneously, in the deltoid (unspecified side), (concentration was not provided). Concomitant medications were not reported. On an unspecified date in May 2016, the patient experienced swelling at injection site and up to the submandibular glands. According to the reporter, on 16-MAY-2016 swelling had "gone down some" compared to how it was on 15-MAY-2016. No laboratories were performed. It was also reported that there was no intervention to prevent serious criteria; significant disability or hospitalization and the events were not considered life threatening. There was no product quality complaint (PQC) involved. At the time of reporting, the outcome of swelling face, injection site swelling and local swelling was unknown. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Activities of daily living impaired, Pain, Swelling
Clinical narrative: Disabling pain and swelling x 7 days after vaccine. Patient could not exercise with shoulder and needed wife to massage at night to try to relieve pain.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Influenza like illness, Malaise, Myalgia, Pain in extremity
Clinical narrative: Severe muscle soreness/pain (R) arm. General malaise/flu like symptoms. Member left work early on 6/9/16 due to symptoms.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Movement disorder, Swelling
Clinical narrative: Patient c/o symptoms to vaccinator approx 7 weeks after vaccination. Symptoms of disabling pain in (L) shoulder joint for over 7 days. Pt had limited movement and swelling.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Influenza like illness, Joint swelling, Joint warmth, Myalgia
Clinical narrative: Major (L) muscle soreness, throbbing, joint felt warm and swollen. Joint aches, H/A low-grade fever, flu-like symptoms x >72 hours after onset.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Major (L) muscle soreness, throbbing, joint felt warm and swollen. Joint aches, H/A low-grade fever, flu-like symptoms x >72 hours after onset.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Loss of consciousness, Nausea, Pain in extremity
Clinical narrative: Approx 1 minute after receiving vaccine - patient felt excruciating pain in arm, and almost lost consciousness. Pt was sat down and given emesis basin due to severe nausea. Symptoms subsided after approx 10 minutes. Member deferred from future anthrax vaccine.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Injection site erythema
Clinical narrative: 6/1 was shot. On 6/2 she noticed there was still pain but it was under the right axilla. There was redness starting 1 inch from injection, forming a line to axilla. Starting 20mg Prednisone for 5 days, starting today.
Sex: M
Vaccine: VARZOS
Symptoms: Allergy test positive, Hypersensitivity, Urticaria
Clinical narrative: Information has been received from a physician referring to a male patient of unknown age (elder than 40 years old). In 2015 the patient was vaccinated with ZOSTAVAX (lot#, dose, dose# and route unknown). The patient experienced hives all over body shortly after administration (in 2015). That could not be supervised without long term prednisone. Testing ruled out other causes, including cancer. Allergic testing identified that was definitely an allergic response, included by strong immune globulin (IG) g response. The patient was currently on medication for allergic reaction under the care of allergist (post approximately 1 year). The patient's medical history included that the patient received multiple immunizations without similar response. In high strep environment prior to administration of ZOSTAVAX at work. The outcome of the vent was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple, unspecified patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored doses (temperature 15F for 3 hours) of PROQUAD, therapy type: HSA, lot# L008355 (expiry date: 11-SEP-2016); lot# L007229 (expiry date: 03-SEP-2016): lot# L002421 (expiry date: 23-JUL-2016) (dosage not reported). No adverse effects reported. The multiple, unspecified patients were exposed to previous temperature excursion; a high temperature of 21F for 14 hours. The cumulative time out of range was 17 hours, including this excursion. The temperature was back in range. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Nurse refers to a 12 month old infant. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 23-MAY-2016, the patient inadvertently received concomitant first doses of VARIVAX lot # L048466 (expiry date: 02-DEC-2017) and PROQUAD therapy type: rHA, lot # L046510 (expiry date: 19-MAY-2017) in opposite legs. No adverse effects reported. No PQC (Product Quality Complaint) reported, PROQUAD was inadvertently pulled from freezer where M-M-R II was stored. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, swelling at injection site. Unable to lift arm above shoulder. Treatment: Ibuprofen and ice.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: 6-3-16 Pt. received PREVNAR 13 vaccine during an annual physical appt. -> Pt. stated arm (left deltoid area) was sore, so she took TYLENOL. 6-4-16 Pt. noted red/swollen arm that gradually increased to cover upper arm from injection site to elbow. 6-9-16 Pt. just reporting the reaction in clinic, given BENADRYL 25 mg PO and prescribed Prednisone.
Age: 17.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dizziness, Loss of consciousness, Pallor, Presyncope
Clinical narrative: After receiving 2 of 4 requested vaccines, pt. reported feeling faint. Lost consciousness x 1 min, pale, blood pressure 80/54. EMS called. Had a vasovagal reaction. Recovered and discharged home after 30 minutes.
Age: 0.8
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 37 week and 4 day old female patient. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On 24-MAY-2016, the patient was vaccinated with the third dose of ROTATEQ orally, (lot # L038536, expiration date 19-AUG-2017) (dose was not provided). Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 70 year old female patient. The patient's concurrent conditions and medical history were not reported. On 13-MAY-2016, the patient was vaccinated with a unspecified dose of ZOSTAVAX which had a lot # of L033790, expiration date of 30-DEC-2016, injected in the left arm (concentration, dose and route were not reported). Information regarding concomitant therapies were not reported. On 14-MAY-2016, the patient did not notice any problems. Then on 15-MAY-2016, the patient woke up and noticed that her arm was "super swollen", very painful, and that there was a knot in her arm. Nevertheless, it was unknown if there was any relevant laboratory test performed. At the time of reporting, the outcome of pain in extremity, peripheral swelling, and nodule was unknown. Additionally, the reporter did not provide a causality assessment between the events and ZOSTAVAX. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MENB, MNQ, PNC13
Symptoms: Dizziness, Loss of consciousness, Vomiting
Clinical narrative: Observed for 15 minutes after vaccine administration, no s/s of dizziness - lightheadedness; walked to car where mother states he passed out in passenger seat. Upon my arrival to car, pt had came to and sat up. Stated he felt lightheaded, gave juice, vomited after finishing juice, ate Nutri-Grain bar. No c/o dizziness no injuries mother and pt stated had not eaten today.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Disturbance in attention, Incoherent
Clinical narrative: Incoherent speech and found it impossible to get his attention.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site reaction, Product preparation error, Skin discolouration
Clinical narrative: Initial unsolicited misuse report received from LVN (Licensed vocational Nurse) on 18 May 2016. This case involves two-month-old male patient (reported as eight-weeks-old) who received 2 vials of ACTHIB diluents as dose 2, 0.4 percent of HIB (PRP/T) VACCINE (ACTHIB) (Diluent batch number: UI537AA, expiration date: 04 November 2017, dose was not reported), was vaccinated with first dose of PNEUMOCOCCAL CONJUGATE VACCINE (PCV 13) (Manufacturer: Pfizer, Batch number: M16259, expiration date and dose was not reported) and a first dose of PEDIARIX (Manufacturer: GSK, Batch number: 4922C, expiration date and dose was not reported) all by intramuscular route in the left thigh on 17 May 2016. Patients Illness at time of vaccination reported as well child visit and pre-existing physician diagnosed allergies, birth defects, and medical conditions were reported as none. On 17 May 2016, same day post vaccination, the patient had experienced redness and mottling around the left knee. It was reported that 2 ACTHIB diluents 0.4 percent vials was administered. It was also a case of product preparation error and product use issue. Laboratory investigations and corrective treatment were not reported. The patient was recovering from the events. It was reported that the evaluating physician stated the events may be a vaccine reaction. List of documents held by sender: none.
Age: 32.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 32 years old patient of unknown gender. The patient's medical history and concurrent condition were not reported. On 25-MAY-2016, the patient was intended to receive M-M-R II and VARIVAX, but was inadvertently vaccinated with a dose of PROQUAD (dose, route, lot # and expiration date not reported) and a dose of VARIVAX (dose, route, lot # and expiration date not reported) due to nursing error. No adverse effects were reported. Additional information is not expected.
Age: 33.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 33 year old patient patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in unspecified deltoid, lot # L042846, expiration date: 15-SEP-2017). No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 49 degree Fahrenheit. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L033707, expiration date: 18-MAY-2017) (dose and route unspecified). These vaccines were exposed to 31.5 degree Fahrenheit for 208 Hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Pt was given expired dose.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L044917, expiration date: 05-OCT-2018; Lot# K026666, expiration date: 22-OCT-2016) (dose and route unspecified). These vaccines were exposed to 31.5 degree Fahrenheit for 208 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 48.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 48 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-MAR-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in unspecified deltoid, lot # reported as 042846, expiration 15-SEP-2017). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L032749, expiration date: 04-NOV-2016; Lot # L048460, expiration date: 14-JAN-2017) (dose and route unspecified). These vaccines were exposed to 31.5 degree Fahrenheit for 208 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 24 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in unspecified deltoid, lot # L042846, expiration date: 15-SEP-2017). No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by post office.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Anal incontinence, Bladder dysfunction, Borrelia test positive, Burning sensation, Dysgeusia
Clinical narrative: The very next day after vaccine I developed a severe headache with sensitivity to light and sound. Then I had tingling and numbness in extremities, loss of bowl movement and bladder function. Eyes moving up and down. Metal taste in mouth, all over body twitching and muscle spasms, sever burning and neuropathy and much more. Lost 30 pounds in weight. After almost 1 year testing at neurologist and various doctors got Lyme disease test and tested positive. The flu shot suppressed my immune system so much that I developed Lyme.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram normal, Eye movement disorder, Headache, Hyperacusis, Hypoaesthesia
Clinical narrative: The very next day after vaccine I developed a severe headache with sensitivity to light and sound. Then I had tingling and numbness in extremities, loss of bowl movement and bladder function. Eyes moving up and down. Metal taste in mouth, all over body twitching and muscle spasms, sever burning and neuropathy and much more. Lost 30 pounds in weight. After almost 1 year testing at neurologist and various doctors got Lyme disease test and tested positive. The flu shot suppressed my immune system so much that I developed Lyme.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Immunosuppression, Laboratory test normal, Lyme disease, Muscle spasms, Muscle twitching
Clinical narrative: The very next day after vaccine I developed a severe headache with sensitivity to light and sound. Then I had tingling and numbness in extremities, loss of bowl movement and bladder function. Eyes moving up and down. Metal taste in mouth, all over body twitching and muscle spasms, sever burning and neuropathy and much more. Lost 30 pounds in weight. After almost 1 year testing at neurologist and various doctors got Lyme disease test and tested positive. The flu shot suppressed my immune system so much that I developed Lyme.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Neuropathy peripheral, Nuclear magnetic resonance imaging normal, Paraesthesia, Photophobia, Somatosensory evoked potentials
Clinical narrative: The very next day after vaccine I developed a severe headache with sensitivity to light and sound. Then I had tingling and numbness in extremities, loss of bowl movement and bladder function. Eyes moving up and down. Metal taste in mouth, all over body twitching and muscle spasms, sever burning and neuropathy and much more. Lost 30 pounds in weight. After almost 1 year testing at neurologist and various doctors got Lyme disease test and tested positive. The flu shot suppressed my immune system so much that I developed Lyme.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Weight decreased
Clinical narrative: The very next day after vaccine I developed a severe headache with sensitivity to light and sound. Then I had tingling and numbness in extremities, loss of bowl movement and bladder function. Eyes moving up and down. Metal taste in mouth, all over body twitching and muscle spasms, sever burning and neuropathy and much more. Lost 30 pounds in weight. After almost 1 year testing at neurologist and various doctors got Lyme disease test and tested positive. The flu shot suppressed my immune system so much that I developed Lyme.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient on an unknown age. Information regarding the patient's pertinent medical history and drug reaction/allergies was not reported. Concomitant therapies included ibuprofen. On an unknown date, the patient was vaccinated with GARDASIL (lot number, expiration date, dose and route of administration were not reported). On an unknown date, after vaccination with GARDASIL, the patient experienced severe fatigue, headache and malaise. It was reported that the symptoms lasted approximately 5 days, but the patient' status was unknown. There was no product quality complaint. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L026602, expiration date: 19-OCT-2017; Lot# L037339, expiration date: 09-FEB-2018) (dose and route unspecified). These vaccines were exposed to 31.5 degree Fahrenheit for 208 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 28.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 28 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-MAR-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in unspecified deltoid, lot # L042846, expiration date: 15-SEP-2017). There was no adverse effect reported. On an unspecified dates from 03-JAN-2016 to 24-FEB-2016, the vaccine was exposed to 49 Fahrenheit degree (the exact length of time out of range could not be determined). This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy technician referring to multiple unspecified patients (age and gender unknown). The patients' concurrent conditions, concomitant medication and medical history were not provided. On multiple unspecified dates, the patients received doses improperly stored ZOSTAVAX 19400 PFU (lot # L039095/expiry date 08-JAN-2017, lot # was reported as L046929/expiry date 17-FEB-2017, lot # was reported as L046295/expiry date 17-FEB-2017, dose and route were unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 68 year old unpregnant female patient. Pertinent medical history and drug reactions/allergies were not reported. Approximately in 2012 when the patient was 65 years old (reported as approximately 3 to 4 years ago), the patient was vaccinated with 1 shot of ZOSTAVAX (dose, lot# and expiration date were not reported) subcutaneously. Concomitant drug was not reported. Around 31-MAY-2016 (reported as about 3 days ago), the patient visited the physician with shingles which had happened since an unknown date. It was a traditional case with blistering and redness on a unilateral dermatome. No lab diagnostics studies were performed. The patient was prescribed unspecified antivirals and painkillers and she was recovering. The causality was not reported. Additional information has been requested.
Age: 53.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 53 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-JAN-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in arm, lot # L038499, expiration date 26-JUN-2017). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Age: 52.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 52 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-JAN-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in the left deltoid, lot # L038499, expiration date 26-JUN-2017). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy technician referring to multiple unspecified patients (age and gender unknown). The patients' concurrent conditions, concomitant medication and medical history were not provided. On multiple unspecified dates, the patients received doses improperly stored VARIVAX (lot# L034368/expiry date 08-SEP-2017, lot # L046887/expiry date 23-NOV-2017, dose and route were unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 36.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 36 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-JAN-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in left deltoid, lot # L038499, expiration date 26-JUN-2017). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy technician referring to multiple unspecified patients (age and gender unknown). The patients' concurrent conditions, concomitant medication and medical history were not provided. On multiple unspecified dates, the patients received doses improperly stored PROQUAD (lot # L045678/expiry date 09-MAY-2017, lot # L045676/expiry date 09-MAY-2017, dose and route were unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Lightheaded, nausea, vomited four times, and headache; donor advised he felt better eight hours after initial onset of symptoms. No treatment was given since patient did not notify provider and did not seek medical care.
Age: 29.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 29 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-JAN-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in right deltoid, lot # L038499, expiration date 26-JUN-2017). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Age: 43.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 43 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-JAN-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in the left deltoid, lot # L038499, expiration date 26-JUN-2017). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Emesis, headache and low grade fever.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Injection site pain, swelling, redness, bruising, hard lump present.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site swelling
Clinical narrative: Injection site pain, swelling, redness, bruising, hard lump present.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Mobility decreased, Myalgia
Clinical narrative: Joint pain through my body - especially left hip, right shoulder, left knee, muscle pain in left leg, left foot, right thumb - increased in following days to severe pain and loss of movement.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 19 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided. On 11-MAR-2016, the patient was vaccinated with an improperly dose of RECOMBIVAX HB (lot# L042846, expiration date 15-SEP-2017) 1 ml, intramuscularly in unspecified deltoid. No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Rash, Swelling
Clinical narrative: Redness, pain, swelling, skin rash.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Myalgia
Clinical narrative: Myalgia.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt states he iced it and tried anti-inflammatory, did not help. Pt presented to the ER with redness, swelling at injection site and afebrile.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Localised oedema, Rash
Clinical narrative: Pt's PCP, reports ADR to PREVNAR 13 on 07/13/2015. Reaction was mild localized edema per PCP. Rash.
Age: 25.0
Sex: M
Vaccine: DT
Symptoms: Pyrexia
Clinical narrative: Fever.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were administered improperly stored doses of VAQTA lot # M003011 with expiration date 15-NOV-2017 (dose and route of administration not reported). The vaccine underwent a temperature excursion of 0.5 degrees Celsius for 2 hours. Digital Data Logger was involved. There was no previous temperature excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were administered improperly stored doses of PNEUMOVAX 23 lot # L019836 with expiration date 24-MAR-2017 (dose and route of administration not reported). The vaccine underwent a temperature excursion of 0.5 degrees Celsius for 2 hours. Digital Data Logger was involved. There was no previous temperature excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 26.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 26 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L042846, expiration date 15-SEP-2017) 1 ml, intramuscularly in unspecified deltoid. No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were administered improperly stored doses of GARDASIL lot # K010574 with expiration date 08-APR-2017 and lot # K014191 with expiration date 10-MAY-2017 (dose and route of administration not reported). The vaccine underwent a temperature excursion of 0.5 degrees Celsius for 2 hours. Digital Data Logger was involved. There was no previous temperature excursions. No adverse effects 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 nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were administered improperly stored doses of RECOMBIVAX HB lot # M001578 with expiration date 21-NOV-2018 (dose and route of administration not reported). The vaccine underwent a temperature excursion of 0.5 degrees Celsius for 2 hours. Digital Data Logger was involved. There was no previous temperature excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 67 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in left deltoid, lot # L042846, expiration date: 15-SEP-2017). No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-JUN-2015, the patient was vaccinated with a dose of GARDASIL lot # K011325 with expiration date: 08-APR-2017 (dose and route of administration were not reported). On 04-JUN-2015, the patient received a dose of GARDASIL 9 lot# L013429 with expiration date: 21-JUL-2017 (dose and route of administration were not reported) and on 28-MAR-2016, the patient received another dose of GARDASIL 9 lot# L037339 with expiration date: 09-FEB-2018 (dose and route of administration were not reported). There were no adverse effects reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were administered improperly stored doses of ROTATEQ orally, lot # L028645 with expiration date 25-MAY-2017 and lot # L033693 with expiration date 31-MAY-2017 (dose not reported). The vaccine underwent a temperature excursion of 0.5 degrees Celsius for 2 hours. Digital Data Logger was involved. There was no pervious temperature excursions. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Pt. states "a few hours after TDAP, I started to get hives on my stomach and my arms and then I started with a fever." When questioned she stated that her fever got as high as 101.2. She states she tried lotion on her hives. Patient report adverse event on 6/10/16 at 10:15 AM.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Computerised tomogram head, Fatigue, Headache, Hyperacusis
Clinical narrative: Severe headache, light and sound sensitivity, lethargy and fatigue.  ED visit, lumbar puncture and CT of the head completed.  Lab work sent.  Has had numerous ER visits and hospitalzations since this initial visit.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Lethargy, Lumbar puncture, Migraine, Nerve block
Clinical narrative: Severe headache, light and sound sensitivity, lethargy and fatigue.  ED visit, lumbar puncture and CT of the head completed.  Lab work sent.  Has had numerous ER visits and hospitalzations since this initial visit.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Photophobia
Clinical narrative: Severe headache, light and sound sensitivity, lethargy and fatigue.  ED visit, lumbar puncture and CT of the head completed.  Lab work sent.  Has had numerous ER visits and hospitalzations since this initial visit.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Blood test, Gait disturbance, Immediate post-injection reaction, Myalgia
Clinical narrative: Arm and joint pain was immediate and continues to this date. Pneumococcal vaccine PCV 13. I have had severe joint and muscular pain in my shoulder elbow knee and ankles on 6/6/2016 pain in my knees I can't walk without severe pain I saw my doctor he had no reason for the pain he order blood work to try to find out what wrong this test will cost 149.00 I have not had nothing like this before I got the vac at pharmacy the person that give me the vac called the co but they did not give him much information I want to know if you all will do anything or have check in to this matter my arm that I had the vac in still hurt.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm and joint pain was immediate and continues to this date. Pneumococcal vaccine PCV 13. I have had severe joint and muscular pain in my shoulder elbow knee and ankles on 6/6/2016 pain in my knees I can't walk without severe pain I saw my doctor he had no reason for the pain he order blood work to try to find out what wrong this test will cost 149.00 I have not had nothing like this before I got the vac at pharmacy the person that give me the vac called the co but they did not give him much information I want to know if you all will do anything or have check in to this matter my arm that I had the vac in still hurt.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Redness and painful lump in area of injection. Will be taking BENADRYL during non-working hours.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Petechiae, Skin disorder
Clinical narrative: Pt called on PM shift approximately 6 hr after TDaP vaccine. pt called to complain of (R) arm swelling and "dot". No SOB. Inst. to go to ER. Went to MD dx petechia.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pain in extremity, Peripheral swelling, X-ray
Clinical narrative: Arm stiff, pain, swollen.
Age: 44.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Blister, Discomfort, Fatigue, Formication
Clinical narrative: BLISTERING AND PEELING OF SKIN, LESIONS ON FACE AND NECK OOZING, DRAINING AND CRUSTING, GENERALIZED PRURITUS, BURNING SKIN, CRAWLING FEELING ON SKIN, GENERAL MALAISE, POLYARTHRALGIA, POLYMYALGIA, EXTREME FATIGUE AND DISCOMFORT, HEADACHES.
Age: 44.0
Sex: F
Vaccine: ANTH
Symptoms: Headache, Malaise, Myalgia, Pruritus generalised, Scab
Clinical narrative: BLISTERING AND PEELING OF SKIN, LESIONS ON FACE AND NECK OOZING, DRAINING AND CRUSTING, GENERALIZED PRURITUS, BURNING SKIN, CRAWLING FEELING ON SKIN, GENERAL MALAISE, POLYARTHRALGIA, POLYMYALGIA, EXTREME FATIGUE AND DISCOMFORT, HEADACHES.
Age: 44.0
Sex: F
Vaccine: ANTH
Symptoms: Secretion discharge, Skin burning sensation, Skin exfoliation, Skin lesion
Clinical narrative: BLISTERING AND PEELING OF SKIN, LESIONS ON FACE AND NECK OOZING, DRAINING AND CRUSTING, GENERALIZED PRURITUS, BURNING SKIN, CRAWLING FEELING ON SKIN, GENERAL MALAISE, POLYARTHRALGIA, POLYMYALGIA, EXTREME FATIGUE AND DISCOMFORT, HEADACHES.
Age: 1.77
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient showing redness and swelling on upper left thigh. Followed up by provider.
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Injection site inflammation, Injection site nodule, Injection site swelling
Clinical narrative: Swollen right thigh with inflammation and knot; Excessive crying up to 3 days after; PREVNAR and Hib given.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Pain in extremity
Clinical narrative: Patient called the pharmacy where she got the shot this morning and said her arm was in severe pain and that the area around the injection site was red, inflammed, swollen and filled with fluid.
Age: 8.0
Sex: F
Vaccine: HEPAB, IPV, MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given an adult dose of TWINRIX in error.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Administered vaccine IM in right deltoid. Immediately developed one large hive around the administration site the size of a quarter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Patient noticed redness (2in diameter, swelling, and itching at injection site the day after vaccination. She also could feel a lump by the injection site. She had a headache only the day after vaccination. A week after vaccination, she reported the incident to our pharmacy (where the vaccine was administered). At the time of the adverse event being reported 6/10/16 11 AM she had no swelling, less redness than the day after vaccination, and itching at the injection site (no other symptoms of allergic reaction). She was told to put cold compresses to the site and to take an antihistamine.
Age: 58.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, tenderness at injection site.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blood alcohol normal, Cerebrovascular accident, Computerised tomogram normal, Drug screen negative, Hypoaesthesia
Clinical narrative: Patient experienced nausea, vomiting, numbness and tingling. Stroke like symptoms caused patient's mother to report to Hospital.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Nuclear magnetic resonance imaging, Paraesthesia, Pregnancy test urine negative, Vomiting
Clinical narrative: Patient experienced nausea, vomiting, numbness and tingling. Stroke like symptoms caused patient's mother to report to Hospital.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Cellulitis, Dizziness, Pain, Pyrexia
Clinical narrative: CELLULITIS SHOULDER TO ELBOW, GENERALIZED ACHES, PAIN, DIZZINESS, WEAKNESS, FEVER.
Age: 12.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Eye movement disorder, Malaise, Syncope, Tremor
Clinical narrative: Mother stated 10 min after leaving the room, the client stated he was not felling well and  started shaking and his eyes rolled back into his head and he collapsed into her arms.
Age: 12.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Blood test, Dizziness, Electrocardiogram, Gaze palsy, Opisthotonus
Clinical narrative: Mother stated 10 min after leaving the room, the client stated he was not felling well and  started shaking and his eyes rolled back into his head and he collapsed into her arms.
Age: 12.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Pallor, Tremor, Visual impairment
Clinical narrative: Mother stated 10 min after leaving the room, the client stated he was not felling well and  started shaking and his eyes rolled back into his head and he collapsed into her arms.