chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 13 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 24-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot # N002720, expiration date 12-MAY-2019) (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA010537: US-009507513-1709USA012774: US-009507513-1709USA012776: US-009507513-1709USA012777.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 10-APR-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 which had the lot # M043731, expiration date 22-JUN-2019, lot # M040412, expiration date 30-JUN-2019, lot # N000326, expiration date 14-OCT-2019, lot # N007931, expiration date 17-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 10-APR-2017, the patients were vaccinated with improperly stored doses of PROQUAD, for prophylaxis (dosage information, route, lot number and expiration date were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA007325: US-009507513-1709USA012764: US-009507513-1709USA012766.
Age: 0.42
Sex: U
Vaccine: RV5, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 10-APR-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, for prophylaxis (dosage information, lot number and expiration date were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA007325: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766.
Age: 1.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 23-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of VAQTA which had the lot # N005274, expiration date 03-APR-2018, N008823, expiration date 26-MAY-2018 and N014945, expiration date 31-AUG-2018, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 23-AUG-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of VARIVAX which had the lot # N008829, expiration date 16-MAR-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 34°F and the higher was 50°F for 46 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 6 months old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 05-JUL-2017, the patient was vaccinated with the third dose of ROTATEQ (lot # M002254, expiration date 15-NOV-2017) (oral, dose was not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) on 13-JUN-2017, which lasted for a 18 hours. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA010591: US-009507513-1708USA005381: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012777: US-009507513-1709USA012776.
Sex: U
Vaccine: 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 or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 29-AUG-2017, the patient was vaccinated with improperly stored VARIVAX (exact dose, dose number, route of administration were not reported; lot # M035687 with the expiration date of 10-AUG-2018), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot # and expiration date were not reported). No adverse effects were reported. The administered dose of VARIVAX underwent a temperature excursion between 6 and 14 degrees Fahrenheit for 20 days. There were no previous temperature excursions reported. Digital data logger was involved to capture the temperature excursion. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA009779.
Age: 1.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 13 months old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 11-JUL-2017, the patient was vaccinated with the first dose of ROTATEQ (lot # M040270, expiration date 29-APR-2018) (oral; dose was not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) on 13-JUN-2017, which lasted for a 18 hours. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA010591: US-009507513-1708USA005381: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012774: US-009507513-1709USA012777.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 6 months old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 07-JUL-2017, the patient was vaccinated with the third dose of ROTATEQ (lot # M002254, expiration date 15-NOV-2017) (oral, dose was not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) on 13-JUN-2017, which lasted for a 18 hours. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA010591: US-009507513-1708USA005381: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012727: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732: US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012776: US-009507513-1709USA012774.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a 91-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with ZOSTAVAX, 19400 plaque forming units (PFU), subcutaneously (dose, lot # and expiration date were not reported) for prevention of herpes zoster. On an unknown date, after receiving the vaccine, the patient developed shingles on their back. The outcome of the event and the relatedness between the event and ZOSTAVAX were not reported.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Injection site erythema, Pain, Pain in extremity, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 69 year old female patient with no pertinent medical history and no drug reactions/allergies. Concomitant therapies included pantoprazole, escitalopram and insulin. The patient's concurrent conditions were not reported. On 20-SEP-2017, the patient was vaccinated with an improperly stored PNEUMOVAX 23 intramuscularly, lot # N011491 with expiration date of 04-NOV-2018, for prophylaxis (strength, dose and frequency were not reported). Other suspect therapies included FLUZONE, it was unknown if it was kept at recommended storage conditions. On an unknown date in September 2017, the patient had "redness at the site that traveled down her arm", "hurting arm", "joints achy" and "felt achy all over" in her left arm. The patient did seek the physician and received treatment for the adverse events, including BENADRYL, ranitidine, and Z PACK. She did not performed laboratories, did not need interventions to prevent serious criteria, did not have disability or incapacity, did not need hospitalization, and no life threatening was present. The outcome of pain in extremity, arthralgia and erythema was reported as not recovered/not resolved. It was stated that the vaccines underwent a temperature excursion of 54.8°F (degrees Fahrenheit) for 1.5 hours; no previous temperature excursion was done. The call was because of a "data logger". The causality between pain in extremity, arthralgia and erythema with PNEUMOVAX 23 was not reported. Sender's Comments: US-009507513-1709USA012780.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On approximately September 2016, reported as "a year ago", the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not reported). On an unknown date, the patient had swelling, redness, and pain on the vaccinated arm. The outcome of swelling, erythema and pain in extremity was unknown. The causality between swelling, erythema and pain in extremity with PNEUMOVAX 23 was not reported. Sender's Comments: US-009513507-1709USA011967.
Sex: U
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Initial unsolicited report received from pharmacist on 08-Sep-2017. This case involves a patient (age and sex not reported) who was vaccinated with dose of FLUZONE HD (batch number, expiry date route and site was unknown) on an unknown date. The patient's medical history and concomitant medications were not reported. On unknown dates, following the vaccination, the patients experienced reaction after a FLUZONE HD injection on the inside of arm and not injection site. It was hot to the touch. The patient's laboratory data and corrective treatment were not reported. The event outcome was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, UNK
Symptoms: Invasive ductal breast carcinoma
Clinical narrative: Initial unsolicited report received from the literature on 15-Sep-2017. This case is linked with: 2017SA173163 (same literature). Abstract: This is the second phase 1 study of a respiratory syncytial virus (RSV) vaccine containing RSV fusion protein (sF) adjuvanted with glucopyranosyl lipid A (GLA) in a squalene-based 2% stable emulsion (GLA-SE). In this randomized, double blind study, 261 subjects aged _60 years received inactivated influenza vaccine (IIV), a vaccine containing 120 _g sF with escalating doses of GLA (1, 2.5, or 5 _g) in SE, or a vaccine containing 80 _g sF with 2.5 _g GLA in SE. Subjects receiving 120 _g sF with 2.5 or 5 _g GLA were also randomized to receive IIV or placebo. Immunity to RSV was assessed by detection of microneutralizing, anti-F immunoglobulin G, and palivizumab-competitive antibodies and F-specific gamma interferon enzyme linked immunosorbent spot assay T-cell responses. Higher adjuvant doses increased injection site discomfort, but at the highest dose, the reactogenicity was similar to that of IIV. Significant humoral and cellular immune responses were observed. The 120 _g sF plus 5.0 _g GLA formulation resulted in the highest responses in all subjects and in older subjects. These results confirm previous observations of vaccine tolerability, safety, and immunogenicity and were used to select the 120 _g sF plus 5.0 _g GLA formulation for phase 2 evaluations. This case involves 69-year-old female patient, who was vaccinated with a dose of INFLUENZA VACCINE and dose of 120 microgram of RESPIRATORY SYNCYTIAL VIRAL VACCINE (batch number, expiry date, dose, dose in series site and route of administration were not reported) on an unknown date. The patient's medical history and concomitant mediation was not reported. On an unknown date, 58 days following the vaccination patient had invasive ductal breast carcinoma. The patient laboratory data and corrective treatment were not reported. Outcome of event was not reported. As per the reporter relationship to study dosing was reported as not related. Upon internal review the case was considered as serious because of important medical event: invasive ductal breast carcinoma. List of documents held by sender: none. Sender's Comments: This case concerns a 69 year old female who developed invasive ductal breast carcinoma 58 days post vaccination with Inactivated Influenza vaccine (MFR unknown). Time to onset is compatible with the role of vaccine. Further information including patient's medical history, concomitant medications, previous vaccination and tolerance, additional information regarding patients' medical condition at the time of vaccination would be needed to fully assess this case. Also as FLUZONE along with respiratory syncytial virus (RSV) vaccine [containing RSV fusion protein (sF) adjuvanted with glucopyranosyl lipid A(GLA) in a squalene-based 2% stable emulsion (GLA-SE)] were administered concomitantly the role of each cannot be assessed separately.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: Red-tender irritation at injection site noticed 3 days (9/23/17) ago. reported 9/26/17. (Given 9/13/17).
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Cough, Pyrexia, Wheezing
Clinical narrative: Child not evaluated in office, but mother states wheezing, coughing, and fever 2-3 hours after the immunizations which continued for 3 days.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: 9/20/2017 11:25 AM swelling, redness, heat and blisters at injection site. 9/20/2017 - pt. had appt. with MD, MD advised if R, S inc in size to start antibiotics.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Genital rash, Urticaria
Clinical narrative: At 8pm, patient started with hives on scrotal area, and inguinal area and rectal area. Hives increased to legs. Hives progressed to chest, abdomen , feet, ankles, chin and cheeks of face. Hives worsened over the weekend, and was taking Benadryl at night. Also placed Lotrimin AF on scrotal rash and rash worsened.
Age: 4.0
Sex: M
Vaccine: FLU4, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Developed redness, itchiness, and hive to thigh. Seemed to be mostly related to PROQUAD location.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Joint swelling, Rheumatoid factor increased
Clinical narrative: Migrating Joint pain and swelling, started on left side. It started when he was at home, he was seen by his doctor and got blood labs drawn and some RF factor was coming up on his bloodwork. It sounds like from patient's wife they are not sure if it was caused by flu shot or not.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site rash, Migraine, Pain in extremity, Pyrexia
Clinical narrative: The night after getting her vaccines, the patient reports having a migraine, a great deal of arm pain, and a fever. This persisted through the next evening, and a rash a few inches below the injection site appeared. Today, this rash is still there, but she is feeling about 85% better.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Cough, Fatigue, Influenza like illness, Malaise
Clinical narrative: Been sick with flu like symptoms for 2 weeks without fever. So tired don't want to get out of bed sometimes. Uncontrollable coughing all night. Weakness after little activity.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Tremor
Clinical narrative: Within 2 hours: headache, nausea, chills and uncontrolled shaking. All symptoms resolved by next morning 9/22/17 Less than 12 hours.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Injection site rash
Clinical narrative: STARTED WITH A RASH AROUND THE INJECTION SITE THAT KEPT GROWING. AFTER CONTACTING HIS PRIMARY DOCTOR - HE WAS /DIAGNOSED WITH CELLULITIS. HE SPENT 10 HOURS IN THE EMERGENCY ROOM AND RECEIVED ANTIBIOTICS AT THE HOSPITAL AND WAS DISCHARGED WITH CLINDAMYCIN 150MG (3 CAPS (450MG) THREE TIMES A DAY IN CONJUNCTION WITH A Z-PAK. THEY MARKED THE RASH (WHICH WAS AS BIG AS HIS UPPER ARM) AND INSTRUCTED THE PATIENT TO RETURN IF IT GROWS.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: PT is having severe shooting pain along her right arm. This started after getting the shot and is still having the pain 6 days. Patient says she felt the pharmacist hit the bone and is believes this is the reason for the pain. Patient does not have the means to go see a doctor to be evaluated. Unsure what is the cause of the pain in the arm.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: The patient reported pain and discomfort in right shoulder, at the injection site, 5 days after receiving the injection. The patient was instructed to place a cold compress to the injection site and to take acetaminophen. The pain and discomfort subsided 24 hours later.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient received the Flu shot at her place of employment yesterday. She was seen today at clinic reporting severe right arm pain affecting mobility. She is instructed to schedule Ibuprofen Q8H for next day or 2 taking Tylenol PRN. Frequent Icing and keep moving as tolerated. She is asked to return to clinic if she is not better enough to return to work on Friday.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Chills, Disorientation, Dyskinesia, Lacrimation increased, Mental status changes
Clinical narrative: After HPV vaccine was administered on the left deltoid, patient stated " Oh my God" and she dropped her head to the left side. Patient bended both arms with close fist and had rapid jerking movements for few seconds. Patient was sitting on the chair. Patient was not responding  when mother was calling her. Dr. was called and came inside the room immediately for evaluation. When the doctor came into the room, the patient was making eye contact with the doctor but not speaking and could not tell the doctor where she was. About 30 seconds later, she stated  her name and her age, and mental status returned to baseline. Patient  was tearing up and shivering. Vitals were taken and normal. Dr. determined to be stable and patient had some water. Patient was monitored for 1 hour. After that time, patient left in stable condition. Patient was ambulating in company of her mother. Pediatrician consulted neurology  took who recommended f/u with neurology, who would likely do a workup including EEG and EKG.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Posture abnormal, Unresponsive to stimuli
Clinical narrative: After HPV vaccine was administered on the left deltoid, patient stated " Oh my God" and she dropped her head to the left side. Patient bended both arms with close fist and had rapid jerking movements for few seconds. Patient was sitting on the chair. Patient was not responding  when mother was calling her. Dr. was called and came inside the room immediately for evaluation. When the doctor came into the room, the patient was making eye contact with the doctor but not speaking and could not tell the doctor where she was. About 30 seconds later, she stated  her name and her age, and mental status returned to baseline. Patient  was tearing up and shivering. Vitals were taken and normal. Dr. determined to be stable and patient had some water. Patient was monitored for 1 hour. After that time, patient left in stable condition. Patient was ambulating in company of her mother. Pediatrician consulted neurology  took who recommended f/u with neurology, who would likely do a workup including EEG and EKG.
Age: 23.0
Sex: F
Vaccine: ANTH, FLU4
Symptoms: Fall, Head injury, Loss of consciousness, Nausea, Syncope
Clinical narrative: This morning patient presented to the site as part of screening. At time 1000, patient received immunizations for Anthrax and Influenza. After receiving both immunizations, patient remained in a vaccination chair. She complained of nausea. Suddenly, she lost consciousness, falling forward, striking her left forehead on the Floor. There was no obvious bleeding, or significant visible abnormality. Patient then quickly resumed consciousness, was able to engage with medical providers. Due to the apparent syncope (fainting) with subsequent head injury, emergency services were initiated, and patient was transported to the MC ER by ambulance for observation.   SPC MEEKS was accompanied in the ambulance by her Unit battle buddy SPC AIKENS.  A patient safety report is being completed at the CRDAMC Patient Safety Office.
Age: 57.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness on left deltoid area.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Injection site erythema, Tenderness
Clinical narrative: Patient complained of redness at the injection site and feeling hot and tender to the touch. Was able to move her arm however. Patient instructed to apply ice pack and take acetaminophen.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Oropharyngeal pain, Vaccination complication
Clinical narrative: Sore throat and hoarse voice.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling, Vaccination complication
Clinical narrative: Patient presented day after vaccine with swelling and redness below the injection site. Patient also stated that it felt feverish to the touch. Patient presented to the pharmacy and was advised to seek medical attention.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site bruising
Clinical narrative: The patient presented with a small bruise at the injection site along with bruising below the deltoid going across the arm. In addition, the patient is asthmatic and she reported increase shortness of breath after receiving the shot.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient noted redness, heat and swelling and pain to injection site; also had nausea, dizziness, low grade fever. Patient took ibuprofen for the pain and fever, ER doctor looked at it and stated that it was "cellulitis". Patient worked the rest of her shift.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Nausea, Pyrexia
Clinical narrative: Patient noted redness, heat and swelling and pain to injection site; also had nausea, dizziness, low grade fever. Patient took ibuprofen for the pain and fever, ER doctor looked at it and stated that it was "cellulitis". Patient worked the rest of her shift.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Blood in stool started about 26 hours after Rota was given.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: Seasonal Flu vaccine given at 4:45 PM. At 10:30 PM episode of atrial fibrillation began and continued on and off for 24 hours and counting. Previously atrial fibrillation symptoms had been absent for 3 months and had been very brief in duration for past 9 months.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Flushing, Urticaria
Clinical narrative: Feelings of being flushed and urticarial rash, Benadryl and symptoms have resolved.
Age: 43.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Noted warmth and swelling to (L) upper deltoid area about the size of an closed fist. Client able to use arm C/O pain. Referred to out  MD/ER if worse.
Age: 57.0
Sex: U
Vaccine: FLU4
Symptoms: Hypersensitivity, Malaise, Nasopharyngitis, Oropharyngeal pain, Rash erythematous
Clinical narrative: Patient present today 9/25/17 with information about his allergic reaction symptoms after receiving flu vaccine on 9/19/17 in clinic. After flu vaccine, one day later became sick w/cold S/S and sore throat and next day presented with a rash all over his body. He went to clinic and was seen and treated for possible allergic reaction. He was treated and sent home. Today he continues with itchy rash and will be going to his primary physician. Rash red, itchy and generalized.
Age: 57.0
Sex: U
Vaccine: FLU4
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Patient present today 9/25/17 with information about his allergic reaction symptoms after receiving flu vaccine on 9/19/17 in clinic. After flu vaccine, one day later became sick w/cold S/S and sore throat and next day presented with a rash all over his body. He went to clinic and was seen and treated for possible allergic reaction. He was treated and sent home. Today he continues with itchy rash and will be going to his primary physician. Rash red, itchy and generalized.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Abdominal discomfort, Asthenia, Contusion, Fatigue, Influenza like illness
Clinical narrative: Nausea/upset stomach x 2-3 days. Weakness/fatigue x 2-3 days. Flu-like symptoms x 2-3 days. Bruised/swollen arm(s) x 10 days. No treatment outside, rest.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Nausea, Peripheral swelling
Clinical narrative: Nausea/upset stomach x 2-3 days. Weakness/fatigue x 2-3 days. Flu-like symptoms x 2-3 days. Bruised/swollen arm(s) x 10 days. No treatment outside, rest.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased appetite, Diarrhoea, Discomfort, Full blood count normal, Haematochezia
Clinical narrative: Received 2 months vaccines on 7/24/17. On 7/27 was fussy and uncomfortable. Having loose stools with blood. Breast fed-not feeding well.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Occult blood positive, Ultrasound abdomen normal
Clinical narrative: Received 2 months vaccines on 7/24/17. On 7/27 was fussy and uncomfortable. Having loose stools with blood. Breast fed-not feeding well.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Affective disorder, Crying, Headache, Hyperacusis
Clinical narrative: Skin hurt - stomach upset. Mood became awful. Headache, screaming - crying. Muscles achy.  Noise never heard before.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Screaming, Skin exfoliation
Clinical narrative: Skin hurt - stomach upset. Mood became awful. Headache, screaming - crying. Muscles achy.  Noise never heard before.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Fever onset on Friday 9/22/17, highest recording of 101.1. Rash onset Sunday 9/24/17. Mild case of mostly macular/papular lesions along the back hair line and clavicle down to mid sternum. Per mom, "rash is disappearing, as of 9/26/17 only a few lesions left. No scabbing, and not itchy." Patient attends Daycare, where there was a confirmed case of chicken pox from 9/19/17.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Eye movement disorder, Headache, Immediate post-injection reaction, Malaise, Muscle twitching
Clinical narrative: Patient developed a headache the evening of 9/25 immediately following her vaccines. She woke up today, 9/26 @ 6am to get ready for school. Around 6:15 am, she said that she wasn't feeling well and thought she needed to vomit. She ran for the bathroom and collapsed on the way. The fainting spell lasted approx. 30 seconds - eyes rolled back, muscles twitching.  She didn't remember anything about it once she came to. She was coherent immediately following the event.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Nausea, Syncope
Clinical narrative: Patient developed a headache the evening of 9/25 immediately following her vaccines. She woke up today, 9/26 @ 6am to get ready for school. Around 6:15 am, she said that she wasn't feeling well and thought she needed to vomit. She ran for the bathroom and collapsed on the way. The fainting spell lasted approx. 30 seconds - eyes rolled back, muscles twitching.  She didn't remember anything about it once she came to. She was coherent immediately following the event.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patients mother called today to report that pt had a "small orange sized" hard area that was pink on her left deltoid where vaccine was given, no reported fever but it is sore. Patient to take ibuprofen or Tylenol PRN and can apply ice to area and let provider know if symptoms worsen or do not resolve.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Nervousness
Clinical narrative: Patient reports feeling shaky and extremely cold with chills. He reports that he could not hold the phone or thermometer. He reported that he lied down and woke up around 7 pm. He said he was fine this morning.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Customer was shopping around the store after flu shot and came to the counter complaining that the center of his chest was hurting. Pharmacist asked if he was having difficulty breathing. Patient responded he was breathing fine but his chest was bothering him and he wanted to lie down. Patient sat down near pharmacy and pharmacist called manager over. Patient said the pain started to get progressively worse therefore making it difficult to breathe so EMS was called. Patient BP 110/69 with pulse 80. Patient states only takes Lisinopril and has never had an ADR to vaccine before. Once EMS arrived, patient stated he felt better when lying on bed. EMS brought patient to ER.
Age: 21.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood test, Chest discomfort, Dyspnoea, Fatigue, Immediate post-injection reaction
Clinical narrative: Immediately after receiving the flu shot, I felt itchy all over my torso, arms and neck. I ignored it and went home, but after about 30-40 minutes, I was having progressively more trouble breathing, wheezing, and tightness in the chest. I felt my throat starting to swell, and I gave myself the EPIPENS around 9:30pm. I had continued trouble breathing, so I went to the hospital (Emergency), where I was treated with BENADRYL and steroids and observation until about 2:30 am (treated by Dr). While in intake, blood was drawn and I started to retch and eventually passed out. Reaction subsided once I started the steroids and BENADRYL. Due to physical exhaustion and the late night, I missed class today (morning of 9/26/17) and called out of work this afternoon. I am refilling my prescriptions for EPIPENS, and also taking more prednisone to follow up. I am also scheduling a doctor's visit.
Age: 21.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Loss of consciousness, Loss of personal independence in daily activities, Pharyngeal oedema, Pruritus, Retching
Clinical narrative: Immediately after receiving the flu shot, I felt itchy all over my torso, arms and neck. I ignored it and went home, but after about 30-40 minutes, I was having progressively more trouble breathing, wheezing, and tightness in the chest. I felt my throat starting to swell, and I gave myself the EPIPENS around 9:30pm. I had continued trouble breathing, so I went to the hospital (Emergency), where I was treated with BENADRYL and steroids and observation until about 2:30 am (treated by Dr). While in intake, blood was drawn and I started to retch and eventually passed out. Reaction subsided once I started the steroids and BENADRYL. Due to physical exhaustion and the late night, I missed class today (morning of 9/26/17) and called out of work this afternoon. I am refilling my prescriptions for EPIPENS, and also taking more prednisone to follow up. I am also scheduling a doctor's visit.
Age: 21.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Wheezing
Clinical narrative: Immediately after receiving the flu shot, I felt itchy all over my torso, arms and neck. I ignored it and went home, but after about 30-40 minutes, I was having progressively more trouble breathing, wheezing, and tightness in the chest. I felt my throat starting to swell, and I gave myself the EPIPENS around 9:30pm. I had continued trouble breathing, so I went to the hospital (Emergency), where I was treated with BENADRYL and steroids and observation until about 2:30 am (treated by Dr). While in intake, blood was drawn and I started to retch and eventually passed out. Reaction subsided once I started the steroids and BENADRYL. Due to physical exhaustion and the late night, I missed class today (morning of 9/26/17) and called out of work this afternoon. I am refilling my prescriptions for EPIPENS, and also taking more prednisone to follow up. I am also scheduling a doctor's visit.
Age: 21.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Rash
Clinical narrative: Immediately after receiving the flu shot, I felt itchy all over my torso, arms and neck. I ignored it and went home, but after about 30-40 minutes, I was having progressively more trouble breathing, wheezing, and tightness in the chest. I felt my throat starting to swell, and I gave myself the EPIPENS around 9:30pm. I had continued trouble breathing, so I went to the hospital (Emergency), where I was treated with BENADRYL and steroids and observation until about 2:30 am (treated by Dr). While in intake, blood was drawn and I started to retch and eventually passed out. Reaction subsided once I started the steroids and BENADRYL. Due to physical exhaustion and the late night, I missed class today (morning of 9/26/17) and called out of work this afternoon. I am refilling my prescriptions for EPIPENS, and also taking more prednisone to follow up. I am also scheduling a doctor's visit.
Age: 21.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood test, Chest discomfort, Dyspnoea, Fatigue, Immediate post-injection reaction
Clinical narrative: PATIENT CALLED ON 9/26/17 TO REPORT ADVERSE REACTION, SAID SHE HAD A RASH AND BEGIN TO HAVE DIFFICULTY BREATHING. WENT TO THE EMERGENCY ROOM, HOSPITAL AND TREATMENT INFORMATION WAS NOT RELAYED TO PHARMACY.
Age: 21.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Loss of consciousness, Loss of personal independence in daily activities, Pharyngeal oedema, Pruritus, Retching
Clinical narrative: PATIENT CALLED ON 9/26/17 TO REPORT ADVERSE REACTION, SAID SHE HAD A RASH AND BEGIN TO HAVE DIFFICULTY BREATHING. WENT TO THE EMERGENCY ROOM, HOSPITAL AND TREATMENT INFORMATION WAS NOT RELAYED TO PHARMACY.
Age: 21.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Wheezing
Clinical narrative: PATIENT CALLED ON 9/26/17 TO REPORT ADVERSE REACTION, SAID SHE HAD A RASH AND BEGIN TO HAVE DIFFICULTY BREATHING. WENT TO THE EMERGENCY ROOM, HOSPITAL AND TREATMENT INFORMATION WAS NOT RELAYED TO PHARMACY.
Age: 21.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Rash
Clinical narrative: PATIENT CALLED ON 9/26/17 TO REPORT ADVERSE REACTION, SAID SHE HAD A RASH AND BEGIN TO HAVE DIFFICULTY BREATHING. WENT TO THE EMERGENCY ROOM, HOSPITAL AND TREATMENT INFORMATION WAS NOT RELAYED TO PHARMACY.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis
Clinical narrative: Profuse sweating of the head for about 45 min. Stopped as fast as it started. I was playing cards - 3 others were aware of it.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, swelling, bruise at injection site. Left arm, sub Q.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects. Was given expired vaccine. Dose repeated with this years vaccine.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Child developed hives 1 day post vaccination on left arm at injection site. Also developed hives on ankle area. Benadryl given and much improved by the following day.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count, Injection site discharge, Injection site erythema, Injection site irritation, Injection site oedema
Clinical narrative: Mid to lower upper right arm swelling, redness, edema,  irritation (near elbow area). Scant amount of clear drainage oozing from site, small amount of yellow crusting noted as well.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Injection site swelling, Metabolic function test, Scab
Clinical narrative: Mid to lower upper right arm swelling, redness, edema,  irritation (near elbow area). Scant amount of clear drainage oozing from site, small amount of yellow crusting noted as well.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, swollen, warm to touch. Patient experiencing chills, fever, headache. Applying ice to site and taking ibuprofen. Patient will call doctor if not feeling better or feeling worse by tomorrow.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Injection site red, swollen, warm to touch. Patient experiencing chills, fever, headache. Applying ice to site and taking ibuprofen. Patient will call doctor if not feeling better or feeling worse by tomorrow.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Stomatitis
Clinical narrative: Patient did not have a reaction until later that night  (after pharmacy closed) with symptoms of lip swelling and sores in mouth. She took benadryl and consulted a nurse practitioner. Patient claims to have received benadryl and antibiotic. Patient did not report these events to the pharmacy until 20 days later.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Limb discomfort
Clinical narrative: Whole upper right arm became red, painful, and heavy. Pt has been on Ibuprofen 400mg 1 tid, and also took APAP extra strength. Also applied cold pack.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Impaired work ability, Injection site inflammation, Injection site swelling, Local reaction, Pain
Clinical narrative: Local site reaction, swollen and inflamed.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Raised, warm, red area on arm at the injection site that continued to spread for at least the next 24 hours. The area covered the majority of her upper arm, approximately 3 in wide by 4 in long. Adverse event started soon after injection. The patient saw her doctor 24 hours after vaccination who prescribed Clindamycin 300 mg for 10 days, triamcinolone 0.1% cream, ranitidine 300 mg , and loratadine 10 mg.
Age: 16.0
Sex: M
Vaccine: MNQ, UNK, UNK
Symptoms: Adverse event
Clinical narrative: Oth complications following immunization, init on 2017-09-22.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Was an adult dose not a Peds.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Feeling abnormal, Headache, Pain in extremity
Clinical narrative: CHILD BROUGHT BACK IN BY PARENTS FOR HEADACHE FUNNY FEELING AND PAIN IN ARM. VITALED AND GIVEN IBUPROFEN. MONITORED, CHILD FELT BETTER, AFTER HR DECREASED, CHILD SENT HOME.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Nasal pruritus
Clinical narrative: Patient called the pharmacy today with complaints of a red, raised area around the injection site. The adverse event occurred right after vaccination on 09/23/17. She also complained of an itchy nose. She had done some gardening after getting the flu shot, but already had the reaction on her arm at that point. She took a dose of Benadryl on 09/23/17. I suggested she continue to take Benadryl and monitor for signs of worsening reaction and report any worsening symptoms to her physician.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Dyspnoea, Immediate post-injection reaction, Injection site swelling, Tremor
Clinical narrative: As soon as the pharmacist gave the injection, patient experienced immediate swelling of injection site.  Within the next minute, the injection site swelled up like a lump and patient started to complain that breathing was difficult. Pharmacist grabbed the epinephrine injection from the emergency kit in the pharmacy. Pharmacist instructed the technician to dial 911 and asked for ambulance/EMTs right away.  By this time, patient started to shake uncontrollably and became very anxious. Pharmacist administered epipen to patient and couple minutes later, EMTs showed up. Patient was sent on an ambulance to the nearest hospital.  Patient was given steroid and benedryl at ER and was sent home after couple hours of observation.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal distension, Abdominal pain upper, Chills, Diarrhoea, Hyperhidrosis
Clinical narrative: EXTREME DISTENSION OF THE STOMACH. NO RELIEF. THEN VOMITED AND DIARRHEA. EXTREME PAIN IN STOMACH TRAVELING TO THE RIGHT AND BACK. SHIVERING AND SWEATY!
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: EXTREME DISTENSION OF THE STOMACH. NO RELIEF. THEN VOMITED AND DIARRHEA. EXTREME PAIN IN STOMACH TRAVELING TO THE RIGHT AND BACK. SHIVERING AND SWEATY!
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Abnormal behaviour, Crying, Emotional distress, Irritability, Musculoskeletal stiffness
Clinical narrative: The morning after patient was vaccinated he began acted very differently than his normal extremely happy. self. He almost never cries or fusses and people are astounded at the constant smile on his face. He loves to cuddle but also loves playing independently. First thing this morning pt was screaming a high pitched shriek and was stiff and arching his back when I was changing his diaper. He continued to shriek throughout the day. I have never ever heard this from him. He was very fussy and inconsolable throughout the entire day. He kept pushing away from me, yet wanted to be held and would not play independently at all.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Opisthotonus, Screaming
Clinical narrative: The morning after patient was vaccinated he began acted very differently than his normal extremely happy. self. He almost never cries or fusses and people are astounded at the constant smile on his face. He loves to cuddle but also loves playing independently. First thing this morning pt was screaming a high pitched shriek and was stiff and arching his back when I was changing his diaper. He continued to shriek throughout the day. I have never ever heard this from him. He was very fussy and inconsolable throughout the entire day. He kept pushing away from me, yet wanted to be held and would not play independently at all.