chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 30-DEC-2015, the patient was vaccinated with a dose of RECOMBIVAX HB (concentration, dose, frequency, route of administration, lot number and expiration date were not provided) and subsequently on an unspecified date in February 2016, the patient was vaccinated with RECOMBIVAX HB second dose, (concentration, dose, frequency, route of administration, lot number and expiration date were not provided). According to the reporter, the patient was programmed to receive the third dose of RECOMBIVAX HB on 12-MAY-2016. Concomitant medications were not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a teenage female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with an unidentified Merck HPV vaccine GARDASIL or GARDASIL 9 (dose, route of administration, anatomical location, lot # and expiry date were not specified). On an unknown date, after the vaccination, the patient experienced vasovagal reaction. The outcome of the event and the causality assessment were not provided. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates between end of March 2016 and 23-MAY-2016, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L035127, expiration date 14-SEP-2017 (dose and route of administration were not reported) as a part of immunization series. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 12 degrees Fahrenheit for 2 months (1440 hours) cumulative time. Data logger was not involved, the excursion was recorded manually. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Blood glucose increased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blood glucose increased in a 69-year-old male patient who received BOOSTRIX (batch number 3NS3A, expiry date 18th November 2016). Concurrent medical conditions included diabetes. On 4th May 2016, the patient received BOOSTRIX. In May 2016, less than a month after receiving BOOSTRIX, the patient experienced blood glucose increased. On an unknown date, the outcome of the blood glucose increased was unknown. The reporter considered the blood glucose increased to be unlikely related to BOOSTRIX. Additional details were provided as follows: The patient also received a steroid and antibiotic at the same time along with BOOSTRIX. The patient had discontinued steroid and antibiotics.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Temp to 101.6 reported to service at 8:30 pm. No site reaction, or other sx.
Sex: M
Vaccine: HEP
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call representative and described the occurrence of injection site pain in a male patient who received ENGERIX B. On 28th April 2016, the patient received ENGERIX B. On an unknown date, less than a month after receiving ENGERIX B, the patient experienced injection site pain and injection site nodule. On an unknown date, the outcome of the injection site pain and injection site nodule were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injection site nodule to be related to ENGERIX B. Additional details were provided as follows: The reporter stated that, after receiving a dose of ENGERIX B the patient came back into the office about a month later to report that he was still having some soreness and a hard knot at the injection site. No further information was reported regarding the event. The reporter did not feel comfortable providing further information regarding the event.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # K026533, expiration date: 07-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 48.6 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. Concomitant medications were not reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a published literature article. The objective of this study was to determine whether asthma was associated with an increased risk of vaccine-preventable disease, e.g., breakthrough varicella infection. This was a retrospective population-based case-control study that examined cases of breakthrough varicella among children between 2005 and 2011. Children with a diagnosis of breakthrough varicella infection (infection of >42 days after vaccination) between 2005 and 2011 and two, age- and sex-matched controls were enrolled for each case. Asthma status was determined by using predetermined criteria. Conditional logistic regression models were used to calculate matched odds ratios (OR) and their corresponding 95% confidence intervals (CI). Of the 165 cases and their 330 matched controls, 48% were boys and the mean (standard deviation) age at the index date was 6.6 plus or minus 3.5 years for both cases and controls. Of the 330 controls, 80 (24%) had two doses of the varicella vaccine compared with only 23 (14%) of the 165 cases (OR 0.29 [95% CI, 0.14-0.61]; p approximately 0.001). Children with a history of asthma ever had a higher risk of developing breakthrough varicella compared with those without a history of asthma (adjusted OR 1.63 [95% CI, 1.04-2.55]; p approximately 0.032) when adjusting for elapsed time since the first varicella vaccination and the number of varicella vaccine doses. This retrospective study report was received from the author refers to 495 patients of unknown gender and age. The patients' concurrent condition included asthma. On unknown dates, the patients were vaccinated with VARIVAX (dosing details not provided). No concomitant medications were reported. On unknown dates, the patients experienced breakthrough varicella infection. Outcome of the event was unknown. Author concluded that condition of asthma might be an unrecognized risk factor for breakthrough varicella infection. Children should follow the two-dose VARIVAX policy. Reporting author considered the event to be related to VARIVAX. Additional information has been requested.
Sex: U
Vaccine: RAB
Symptoms: Injury associated with device
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of needle injury in a patient who received RABAVERT. On an unknown date, the patient received RABAVERT. On an unknown date, immediately after receiving RABAVERT, the patient experienced needle injury. On an unknown date, the outcome of the needle injury was unknown. It was unknown if the reporter considered the needle injury to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. The reporter was made aware by a pharmacy buyer at a hospital that the patient was stuck with a vaccine needle. It was unknown if the needle stick occurred after administration or prior to that. The nurse from infection control had advised not to administer with the provided 25 gauge needle provided with the vaccine, but was not this case with this particular patient that experienced the needle stick injury. The agency reported because this occurred at a facility and the report had probably already been shared with agency, but it was not known for sure. The original email came from an Infection Control nurse. The email had been forwarded to GlaxoSmithKline QA department, but a QA had not been filed. The email stated that, they recently had a needle stick associated with the RABAVERT vaccine kit made by GlaxoSmithKline. The kit contained the vaccine, a 21 gauge needle for reconstitution and a 25 gauge needle for administration. The problem was the 25 gauge needle was not safety engineered. The nurse instructed the staff to discard the needle and replace it with a 25 gauge safety needle from their supply. However she was concerned about any manufacturer would place a non-safety needle in a kit when the standard forbids their use. She enquired if there was a kit that contains the safety needles for injection and whether there another manufacturer who provides such a kit.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of oral ROTATEQ lot # L020859, expiration date: 19-JAN-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 48.6 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. Concomitant medications were not reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Cytology abnormal, Expired product administered, Human papilloma virus test positive
Clinical narrative: This spontaneous report as received from a physician via medical records refers to a 29 year old female patient. Patient's medical history included normal PAP Smears (Smear Cervix) (on an unspecified date). Her concurrent conditions included an allergy to amoxicillin and a high grade squamous intraepithelial lesion with Human Papilloma Virus Infection (HPV) DNA+ diagnosed in 2013. Historical drugs included LUTERA. Patient's last menstrual period was on 31-DEC-2014. On 12-JUN-2014, the patient was vaccinated with a first dose of expired GARDASIL (lot # 1702X exp 08-SEP-2011). Then on 14-AUG-2014, the patient was vaccinated with a second dose of expired GARDASIL (lot # 0053X exp. 28-JUL-2010). Finally, on 02-OCT-2014, the patient was vaccinated with the third dose of expired GARDASIL (lot # 0670Y exp. 20-JUN-2010). All doses were administered intramuscularly, in the left deltoid, with a dose of 0.5ml. A PAP smear test and a cone biopsy, performed on 23-JAN-2015 showed a high grade lesion (HSIL) and cervical intraepithelial neoplasm (CIN3) with free margins, respectively. The diagnoses was interpreted as high grade squamous intraepithelial lesion (cervical dysplasia); from moderate to severe dysplasia (CIN 2-3). This was considered as a vaccination failure. At the reporting time, the outcome of the cervical dysplasia was unknown. The causality between the events and therapy with GARDASIL was not stated. No product quality complaint was reported (PQC). The physician stated that he understood that the patient was not virginal at the time that the patient received the vaccine but he thought that maybe the lot numbers could be checked just to make sure about another unexpected outcomes associated with those batches. All available medical records will be provided upon request. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Vaccination failure
Clinical narrative: This spontaneous report as received from a physician via medical records refers to a 29 year old female patient. Patient's medical history included normal PAP Smears (Smear Cervix) (on an unspecified date). Her concurrent conditions included an allergy to amoxicillin and a high grade squamous intraepithelial lesion with Human Papilloma Virus Infection (HPV) DNA+ diagnosed in 2013. Historical drugs included LUTERA. Patient's last menstrual period was on 31-DEC-2014. On 12-JUN-2014, the patient was vaccinated with a first dose of expired GARDASIL (lot # 1702X exp 08-SEP-2011). Then on 14-AUG-2014, the patient was vaccinated with a second dose of expired GARDASIL (lot # 0053X exp. 28-JUL-2010). Finally, on 02-OCT-2014, the patient was vaccinated with the third dose of expired GARDASIL (lot # 0670Y exp. 20-JUN-2010). All doses were administered intramuscularly, in the left deltoid, with a dose of 0.5ml. A PAP smear test and a cone biopsy, performed on 23-JAN-2015 showed a high grade lesion (HSIL) and cervical intraepithelial neoplasm (CIN3) with free margins, respectively. The diagnoses was interpreted as high grade squamous intraepithelial lesion (cervical dysplasia); from moderate to severe dysplasia (CIN 2-3). This was considered as a vaccination failure. At the reporting time, the outcome of the cervical dysplasia was unknown. The causality between the events and therapy with GARDASIL was not stated. No product quality complaint was reported (PQC). The physician stated that he understood that the patient was not virginal at the time that the patient received the vaccine but he thought that maybe the lot numbers could be checked just to make sure about another unexpected outcomes associated with those batches. All available medical records will be provided upon request. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a female patient of unknown age. The patient's concurrent conditions and pertinent medical history were not reported. On 02-MAY-2016, the patient was vaccinated with ZOSTAVAX, 1 shot, subcutaneously. Concomitant therapies included warfarin. On 04-MAY-2016, the patient experienced swelling, pain and redness at the injection site. She contacted her pharmacist, who advised her to take BENADRYL to alleviate the symptoms. The reaction subsequently healed. The reporter did not provide the relatedness of the events with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. In approximately August 2015 (reported as 8 or 9 months ago), the patient was vaccinated with the first dose of unidentified Merck HPV vaccine (name and lot number not provided) (dose and route were not reported). On 19-MAY-2016, the patient received the second dose of GARDASIL (lot# L038135 with expiration date 27-MAY-2017, dose and route were not reported) (inappropriate schedule of drug administration). No adverse event was reported. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Blood in stool x 3 diaper changes starting 05/31/16 at 9 pm.
Age: 35.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Asthenia, Body temperature increased, Nausea, Pain, Rash
Clinical narrative: Temp, weakness, nausea, fluid filled rash to neckline around ears, body aches rash systemic.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Vaccines given on 5/9/16. He developed fever afternoon/eve and was given TYLENOL. Awoke with fever 103.5 and nausea and vomiting. Taken to ER where fever was recorded. Given ibuprofen and ZOFRAN.
Age: 0.1
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 1 month old patient of an unknown gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 31-MAY-2016, the patient was vaccinated with VAQTA (the dose, dosage number, route of administration, anatomical location, lot # and expiration date were not reported). No concomitant medications were reported. Despite being vaccinated at the reported age, no adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Age: 0.27
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Cough, Decreased appetite, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Fever, cough, congestion, runny nose decreased appetite. Patient examined on 12/17/15, on presentation. Tx: diphenhydramine.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L013068, expiration date: 14-APR-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 18 degrees Fahrenheit for 36 minutes. Data logger was involved. There were no previous excursions reported. Concomitant medications were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, Pain, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a female patient who received BEXSERO (batch number 146101A, expiry date 30th April 2016). On 24th May 2016, the patient received BEXSERO .5 ml. In May 2016, less than a week after receiving BEXSERO, the patient experienced pain in arm. On 24th May 2016, the patient experienced expired vaccine used. On an unknown date, the outcome of the pain in arm and expired vaccine used were unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. On 24th May 2016, the patient received a dose of BEXSERO, which was already expired on 30th April 2016. At the date of reporting, the patient called the other healthcare professional with complaints of a shooting pain down arm to wrist. No further information was provided regarding the event. At the time of reporting, the other healthcare professional was not feeling comfortable for providing further patient identifying information.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified numbers of patients. The patient's concurrent conditions, concomitant medication and medical history were not provided. On unknown dates, the patients were vaccinated with an improperly stored dose of ZOSTAVAX (lot # L036823, expiry date 24-DEC-2016, dose and route were unspecified). The reporter stated that the ZOSTAVAX was exposed to the following conditions: Temperature: 12F for 90 minutes; previous temperature excursion: 24F for 8 hours. This report was because of a "data logger". No adverse symptoms was reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Redness, warmth and mild pain at left upper arm - not deltoid treated with ROCEPHIN 1GM IM and P.O. Doxycycline 100mg BID x 7 days and P.O. BENADRYL. Wed May 11th Dr's office I got a pneumococcal shot. Thur 12th I felt fine. Fri 13 and Sat 14 I thought I had the flu I ached all over. Sun 15th my left arm was red and very hot from my elbow up my arm about 3 or 4 inches. Had fever in it. That lasted until May 20th. Mon 16th went back to Dr's office. The PA gave me a shot in my hip and called in for some pills. Wed 18th started taking the pills. Sun 22nd I began to feel better. Pills - Doxycycline Hyclate 100M.
Age: 8.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative refers to a 8 year old child of unknown gender. Information on patient's pertinent medical history, drug reactions/ allergies and concomitant medications were not provided. On an unknown date the patient was vaccinated with GARDASIL dose 1, 20 days before turning 9 years old (route, strength, lot number and expiration date were unreported) (Inappropriate schedule of drug administration). The nurse asked on behalf of physician, if a GARDASIL dose would "count if a patient received the first dose of GARDASIL 20 days before turning 9 years old which is outside of the recommendations in the GARDASIL Quadrivalent prescribing information. No adverse effect reported. No product quality complaints were reported. No further information was provided. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a physician referring to a 26 year old female patient. There was no pertinent medical history or drug reaction/allergy reported. On 11-MAY-2016, while the patient was pregnant, she was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, Lot# and expiration date were not reported) (Medication Error and Vaccine Exposure during Pregnancy). Concomitant therapies included prenatal vitamins. The gestational age was 30 weeks and 4 days as of 11-MAY-2016. The last menstrual period (LMP) date was approximately 09-OCT-2015 and the estimated date of delivery (EDD) was approximately 15-JUL-2016 (calculated from the gestational age). The patient was in the office to seek medical attention. No treatment was given for the events. No lab diagnostics study was performed. At the time of reporting, the outcome of pregnancy was pending. Fetal outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Information has been received from a 25 year old male patient referring to himself. The patient's pertinent medical history and drug reactions/allergies were not reported. On 23-MAY-2016 the patient was vaccinated with one shot of PNEUMOVAX 23 (dose, route and lot# were not reported) which was suggested by physician. Concomitant therapy included ATRIPLA. On 28-MAY-2016, the patient experienced nausea, headache and fatigue after receiving the PNEUMOVAX 23. The patient did not seek medical attention. There was no treatment given for the adverse events. The outcome of the events was reported as not recovered. The causality was not reported. Additional information is not expected as there was no any contact information provided.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: This report was received from a physician assistant via a vendor referring to a 12 year old male patient who was enrolled in a market research. The patient was a healthy kid without any concurrent condition or concomitant therapy. In March 2016 the patient was vaccinated with the first dose of GARDASIL 9 (lot# and expiration date were not reported) intramuscularly. On an unknown date in 2016 the patient went out from exam room and while he was sitting waiting, he fainted/ felt dizzy. There was no lab test was done. The patient recovered from the event with sequelae on the same day (it was also reported as recovering). The reporter stated that the patient tolerated the vaccine and it was unsure that if the issue was that he was nervous about getting blood drawn. The reporter considered the event to be not related to GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unknown dates the patients were vaccinated with VARIVAX lot # L040422, Expiration dates 15-OCT-2017; lot# L049534, expiration date 08-DEC-2017; dose and route were not reported. The vaccines were exposed to 9.8 F for 30 minutes due to a data logger. There was no previous temperature excursion. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unknown dates the patients were vaccinated with PROQUAD (Merck) (lot # L030587, Expiration date 10-FEB-2017; dose and route were not reported). The vaccines were exposed to 9.8 F for 30 minutes due to a data logger. There was no previous temperature excursion. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to two patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # L045956, expiration date 17-NOV-2017 (dose, route and site of administration were not reported). There were no adverse symptoms reported. Administered doses of VARIVAX were exposed to the temperature of -14.4 degrees Celsius for 8 hours and 46 minutes. There were no previous temperature excursions reported. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On an unknown date the patient was inadvertently vaccinated with the third dose of GARDASIL dose 3 (route, strength, dosage, indication, lot number and expiration date were unreported). The reporting pharmacist had limited information. No adverse event was reported. No product quality complaints were reported. No additional information available. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Swelling
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient's pertinent medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency and route were not reported). Concomitant medications were unknown. On an unknown date (reported as several years ago), the patient experienced swelling, redness and rash that lasted for 2 days. The outcome of the events was reported as recovered/resolved. The causality of the events was not reported. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information is not expected as reporter contact details were not reported.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Impaired work ability, Pain, Pain in extremity
Clinical narrative: Pt. rec. 2nd RABAVERT on 5/23/16. Reports severe aching (especially in legs) began that night 5/23. Unable to work 5/24. Symptoms did not resolve until evening of 5/26/16.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration
Clinical narrative: Localized erythema, induration upper arm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Patient noticed redness/swelling at and around injection site the morning of 6-1-16. As of 6-2-16 the area has spread to roughly 7 inches surrounding injection site. Patient reports itching but no pain. The area was swollen as well.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site discomfort, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: 6/1/16 Parent calls to report a localized reaction day after vaccination to (L) deltoid of swelling and discomfort. Counseled to use cool pack/ibuprofen. 6/2/16 Swelling, involved "entire" deltoid area. Pain/swelling improved.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal pain
Clinical narrative: Dull pain in left shoulder got worse with every day activity. Had physical therapy had cortisone injection on 8/11/2015. Nothing helped.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Hypoaesthesia, Skin warm
Clinical narrative: Pt c/o numbness in (L) arm. Feels radiating "hotness" up and down arm. No visible changes noted. Arm strength equal bilaterally.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Abdominal pain, Haematochezia, Intussusception, Therapeutic procedure, Ultrasound abdomen abnormal
Clinical narrative: Patient received ROTARIX on 05/24/16. Presented to ER on 5/28/16 with abdominal pain, vomiting and bloody stool. Ultrasound confirmed intussusception, reduced by radiology.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Patient received ROTARIX on 05/24/16. Presented to ER on 5/28/16 with abdominal pain, vomiting and bloody stool. Ultrasound confirmed intussusception, reduced by radiology.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient has unraised red circle around injection site. No pain, slight itch. About the size of an orange on left arm.
Age: 43.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 26-Oct 2015. The case report was received from a Health Professional and concerns a 43 year old female patient. The patient had no illness at time of vaccination. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 13-Aug-2015 - unknown stop date, batch no: U56006, route of administration: intramuscular, dose: 0.5 ml. Additional suspect drug(s): ZOSTAVAX. Reaction(s)/event(s) and outcome: On 17-Aug-2015, 5 days after starting/treatment with AFLURIA the patient experienced severe itching at site of vaccine (non serious, outcome: unknown), swelling (vaccine site) (non serious, outcome: unknown), redness (vaccine site) (non serious, outcome: unknown). Reporter's assessment: non-serious. VAERS ID: 590153.
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns an 88 year old female patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s) / event(s): The patient received AFLURIA on 05-Aug-2015 - unknown stop date, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml, Site: right arm (RA). Additional suspect drug(s): PREVNAR 13, Site: left arm (LA). Reaction(s) / event(s) and outcome: On an unknown date 1 week following vaccination, after starting /treatment with AFLURIA the patient experienced [Red] swollen area around injection site - left arm 1 week after administration (non serious, outcome: recovered/resolved), Red [swollen] area around injection site - left arm 1 week after administration (non serious, outcome: recovered/resolved). Event treatment: Dr prescribed antibiotic. VAERS ID: 590907. Reporter's assessment: Non-serious.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Cyanosis, Peripheral swelling, Pyrexia
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 26-Oct-2015. The case report was received from a Health Professional and concerns a 56 year old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/ event (s): The patient received AFLURIA in the left arm for indication not reported on 09-Aug-2015- unknown stop date, Batch no: U55106, Route of administration: Unknown, Dose: 0.5 ml. Additional suspect drug (s): PNEUMOVAX in the left arm, Indication: not provided. Both PNEUMOVAX and AFLURIA were given in the same arm (medication error not explicitly reported). Reaction (s)/event (s) and outcome: On 09-Aug-2015, 1 day after starting/treatment with AFLURIA the patient experienced Arm swell/ Peripheral swelling (non serious, outcome: Not Recovered/Not Resolved, Shivering/ Chills (non serious, outcome: Not Recovered/Not Resolved)). On 09-Aug-2015, 4 hours after starting/ treatment with AFLURIA the patient experienced 102F fever (4 hours after shot)/ Pyrexia (non serious, outcome: Not Recovered/Not Resolved). On 10-Aug-2015 15:00, 2 days after starting/ treatment with AFLURIA the patient experienced Lips, fingers, toes turned slightly blue/ Cyanosis (non serious, outcome: Not Recovered/ Not Resolved). Event treatment: Ibuprofen (when he takes ibuprofen slight blue color goes away).
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns 16 year old female patient. The patient had no illness at the time of vaccination. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 23-Dec-2014 - unknown stop date, Batch no: 'TG0207', Route of administration: Intramuscular, Site: unknown. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting / treatment with ALFURIA the patient experienced [Pain and] limited mobility in the shoulder (non serious, outcome: Not Recovered / Not Resolved), Pain [and limited mobility] in the shoulder (non serious, outcome: Not Recovered / Not Resolved). VAERS ID: 591411. Reporter's assessment: Non-serious. Case correction (23-Feb-2016): AE 1 re-coded. Reporter's comments: The health authority reported symptom included 'mobility decreased'.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injury associated with device
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 54 year old female patient. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 24-Aug-2015-unknown stop date, Batch no: U54506, Route of administration: Intramuscular, Dose: 0.5 ml; site: left arm (LA). Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: Upon vaccination, the patient was stuck with a used needle when giving flu shot (non serious, outcome: Unknown), no symptoms or signs. Action taken: Blood work being ordered through physician. VAERS ID: 591571. Reporter's assessment: Non-serious.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 26-Oct-2015. The case report was received from a Health Professional and concerns a 54 year old female patient. Weight: not provided, Height: not provided. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication No indication reported on 05-Aug-2015- unknown stop date, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 07-Aug-2015, 3 days after starting/ treatment with AFLURIA the patient experienced Pain (non serious, outcome: Not Recovered/ Not Resolved).
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 56 year old male patient. Concurrent medical condition (s), medical and drug history: At the time of the event, the patient was undergoing TKA patella component revision. The patient has a medical history of DJD / Osteoarthritis, Seizures, Restless legs syndrome, BPH, Impotence and Lower back pain. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s) / event (s): The patient received AFLURIA on 26-May-2015 - unknown stop date, Batch no: T51208, Route of administration: not provided, Dose: 0.5 ml; site: left arm (LA). Additional suspect drug (s): PNEUMOVAX, site: right arm (RA). Reaction (s) / event (s) and outcome: On 26-May-2015, 1 day after starting / treatment with AFLURIA the patient experienced Sweats (non serious, outcome: Unknown), Erythema (non serious, outcome: Unknown), Pain at injection site (non serious, outcome: Unknown), Low grade fever (non serious, outcome: Unknown), Injection site erythema (non serious, outcome: Unknown). Event treatment: Diphenhydramine 25 mg TID, prednisone 40 mg once. VAERS ID: 591596. Reporter's assessment: Non-serious.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Rash, Swelling face
Clinical narrative: This health authority case was initially received on 26-Oct-2015. The case report was received from a Health Professional and concerns a 48 year old female patient. Weight: not provided, Height: not provide Suspect drug(s), timing and conditions surrounding the onset of reactions(s)/event(s);  The patient received AFLURIA in the left arm on 25-Aug-2015 - unknown stop date, Batch no: U56046, Route of administration: Intramuscular, dose: 0.5 ml. Additional suspect drug(s): PNEUMOVAX in the left arm. Both PNEUMOVAX and AFLURIA were given in the left arm. Reaction(s)/event(s) and outcome: On 28-Aug-2015, 3 days after starting / treatment with AFLURIA the patient experienced swelling in facial area (non serious, outcome: unknown), Elevated blood pressure (non serious, outcome: Unknown), Rash on arm, trunk and neck area (non serious, outcome: Unknown). Event treatment: Patient went to PCP and received blood pressure medication (unspecified). Reporter's assessment: The Health Professional considered the event(s) swelling in facial area, elevated blood pressure, rash on arm, trunk and neck area as non-serious and related. VAERS ID: 592019.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: This case report was received from a Health Professional and concerns a 41 year old female patient. The patient reported no illness at the time of vaccination. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA for indication not reported on 17-AUG-2015, unknown stop date, Batch no: 055706, Route of administration: Intramuscular, Dose: 0.5 ml; site: left arm (LA), Additional suspect drug(s): No additional drugs suspected. Reaction(s) event(s) and outcome: On an unknown date since the date of vaccination, after starting/treatment with AFLURIA the patient experienced pain and movement (non serious, outcome:  Unknown). Soreness around injection site (non serious, outcome: unknown). VAERS ID: 593948. Reporter's assessment: Non-serious. Case correction (23-FEB-2016): The company causality changed to unassessible.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 26-Oct-2015. The case report was received from a Health Professional and concerns a 38 year old female patient. Concurrent medical condition (s), medical and drug history: The patient has a medical history of Asthma. The patient had no illness at the time of vaccination. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 07-Sep-2015- unknown stop date, Batch no: U56206, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On 08-Sep-2015, 2 days after starting/ treatment with AFLURIA the patient experienced Injection site erythema/Red spot of flu shot (non serious, outcome: Recovered/ Resolved), Injection site pruritus/Spot of flu shot was itchy (non serious, outcome: Unknown). VAERS ID: 594189.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: The patient received AFLURIA for indication not reported on 31-AUG-2015 at 09:15 am - unknown stop date, Batch no: U56006, Route of administration: Unknown, Dose: 0.5 ml. On 31-AUG-2015 at 6 pm, after starting / treatment with AFLUIRA the patient experienced Rash from cheeks down to torso/Rash (non serious, outcome: Unknown). The patient was treated with Fexofenadine. The health authority assessed the event was non-serious. VAERS ID: 594341
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Source of report and patient demography: This health authority was received from a (n) Health Professional and concerns a (n) 68 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 26-Aug-2015- unknown stop date, Batch no: U55406, Route of administration: Unknown, Dose: 0.5 ml. Additional suspect drug (s): PREVNAR 13 (batch number: L82219), Indication: not provided. Reaction (s)/event (s) and outcome: On 30-Aug-2015, 5 days after starting/ treatment with AFLURIA the patient experienced Redness from mid delt to elbow (injection site)/injection site erythema (non serious, outcome: Not Recovered/ Not Resolved), Itchy 4 days after (non serious, outcome: Not Recovered/ Not Resolved). For relevant test results see appropriate report section.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: This health authority case was initially received on 26-OCT-2015. This case report was received from a Health Professional and concerns a 34 year old male patient; The patient had no illness at the time of vaccination. The patient received AFLURIA on 29-AUG-2015 - unknown stop date, Batch no: U55106, Route of administration: Unknown, Dose: 0.5 ml. No additional drugs suspected. On 29-AUG-2015, 2 days after starting/treatment with AFLURIA the patient experienced numbness/Hypoesthesia (non-serious, outcome: Not Recovered/Not Resolved, back pain (non serious, outcome: Not Recovered / Not Resolved), (back) pain down to right leg/pain in extremity (non serious, outcome: Not Recovered/Not Resolved). Throbs, soreness, (numbness)/pain (non serious, outcome: Not Recovered/Not Resolved). On 01-SEP-2015, the patient was seen by the doctor. The doctor thought that the patient sprain and was not related. VAERS ID: 594562. The health authority assessed the events as non-serious.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Peripheral swelling, Rash
Clinical narrative: This health authority case was initially received on 26-Oct-2015. This case report was received from a(n) Health Professional and concerns a(n) 57 years old male patient. The patient had no present illness at the time of vaccination. Weight: not provided. Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 30-AUG-2015 - unknown stop date, Batch no: 11049211A, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): PNEUMOVAX. On 30-Aug-2015, 1 day after starting / treatment with AFLURIA the patient experienced swelling of arm/peripheral swelling (non serious, outcome: Recovered / Resolved), pain (non serious, outcome: Recovered / Resolved), rash (non serious, outcome: Recovered / Resolved). The health authority assessed the events as non-serious.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: This case report was received from a(n) Health Professional and concerns a(n) 50 years old female patient. Weight: not provided. Height: not provided. The patient has a medical history of Thyroid disease (hypothyroid). For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on unknown dates, batch no. U55606, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 08-SEP-2015, 1 day after starting / treatment with AFLURIA the patient experienced pain in left arm/pain in extremity (non serious, outcome: not recovered/not resolved, Fever 102/Pyrexia (non serious, outcome: not recovered/not resolved, Nausea (non serious, outcome: not recovered/not resolved), Vomiting (non serious, outcome: not recovered/not resolved). On 08-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced diarrhoea (non serious, outcome: Not Recovered / Not Resolved). On 08-SEP-2015, the patient underwent TB test on the opposite arm (lot number 762020, expiry date: 01-FEB-2017). The health authority assessed the events as non-serious.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Vomiting
Clinical narrative: This case report was received from a Health Professional and concerns a 63 year old female patient. The patient received AFLURIA on 14-SEP-2015 - unknown stop date batch no. U55506, route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On an unknown date, after starting/treatment with AFLURIA the patient experienced diarrhea (non serious, outcome: Recovered/Resolved, Vomiting (non serious, outcome: Recovered/Resolved).