chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare workers refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL, lot # K023432, expiration date: 18-JUN-2016 and lot # reported as L000610, expiration date: 31-JAN-2017, (dose, route of administration and injection site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and unknown gender. On an unspecified date, the unspecified number of patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L007495 with an expiry date of 24-FEB-2017 and lot# L006547 with an expiry date of 07-MAR-2015). No adverse effects were reported. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a 77 year old male patient who refers to himself. The patient's medical history and current conditions were not provided. On an unknown date approximately in 2012 (reported as "about 3 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date and dose were not reported), subcutaneous. Secondary suspects and concomitant therapies were not reported. On an unknown date approximately in August 2015 (reported as "about a month ago"), the patient developed a painful rash on his right hip and leg. The patient sought medical attention via seeing his provider (unspecified provider). It was confirmed that the patient had shingles. The patient was treated with fentanyl patch and NEURONTIN. At the time of the report, the patient was experiencing the pain and rash from shingles. Additional information is not expected due to no consent to contact Health Care Professional was given.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 05-OCT-2015, the patient was vaccinated with expired dose of (Oka/Merck) VARIVAX (dose: 0,5 ml/once, route subcutaneous, lot # J007954, expiration date 27-JUN-2015). There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and unknown gender. On an unspecified date, the unspecified number of patients were vaccinated with doses of improperly stored GARDASIL (lot# K005881 with an expiry date of 14-JAN-2017). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and unknown gender. On an unspecified date, the unspecified number of patients were vaccinated with doses of improperly stored oral, ROTATEQ (lot # K019372 with an expiry date of 16-JUL-2016, lot# K009181 with an expiry date of 24-APR-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a health professional concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history or allergy/drug reactions were not reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL (lot # K006960, expiration date 19-FEB-2017) (strength, dose, route and frequency were not informed). Concomitant therapy was not reported. It was unspecified if there was any adverse event. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This spontaneous report was received from a pharmacist via public representative refers to the two anonymous patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23. Concomitant medication included unspecified flu vaccine. On an unknown date, the patients became sick after vaccination. The outcome of the event was not reported. The reporter did not provide the causality assessment. No product quality complaint (PQC) was filed. No further adverse event information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 15-SEP-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L018001, expiration date: 19-MAY-2017, dose, route unspecified). Other suspect and concomitant therapies were not reported. No symptoms reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site
Clinical narrative: This spontaneous report as received from an adult patient of unknown age and gender, refers to themselves. On 02-OCT-2015, the patient was intramuscularly vaccinated with the first dose of GARDASIL (dose, lot # and expiration date were not provided) in the buttock rather than in the deltoid. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to three patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On 14-SEP-2015 the patients were respectively vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L018001, expiration date: 19-MAY-2017, dose, route unspecified). Other suspect and concomitant therapies were not reported. No symptoms reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to two patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On 17-SEP-2015 the patients were respectively vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L018001, expiration date: 19-MAY-2017, dose, route unspecified). Other suspect and concomitant therapies were not reported. No symptoms reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to a 4 year old patient of unknown gender. No concurrent conditions and medical history were reported. On an unknown date approximately in 2015 (also reported as unspecified time between 25-AUG-2015 and 25-SEP-2015) the patient was vaccinated with second dose of incorrectly stored VARIVAX (Merck) (lot # K008823, expiry date 19-JUN-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was reported. The action taken with the therapy with VARIVAX (Merck) was unknown. The outcome of the events was unknown. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to two patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On 02_SEP-2015 the patients were respectively vaccinated with a dose of improperly stored (Merck) VARIVAX (lot # L018001, expiration date: 19-MAY-2017, dose, route unspecified). Other suspect and concomitant therapies were not reported. No symptoms reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Immediate post-injection reaction, Injection site rash
Clinical narrative: Pt was receiving her routine 2 month vaccines, and after getting her PREVNAR and Hib (PEDVAX) she immediately broke out in a rash around the injection site. The doctor instructed the pt to wait for 20 minutes. Pt waited for the 20 min and when examined the rash had faded tremendously and the doctor allowed the pt to go home. Dr. has referred the pt to see an Allergist.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Large red area by injection site, itching of area, presented itself days after injection.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 1 1/2 inch diameter red spot on arm. Site was observed approximately 28 hrs. post immunization, was warm and swollen. Administered BENADRYL and ice pack. Called nurse line.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Tinnitus
Clinical narrative: Approximately 5 mins after vaccine administered, pt. c/o "pounding" headache, followed by lightheadedness, dizziness, and "ringing in ears". Advissed pt to remain sitting until she felt she could ambulate. After 15 minutes with pt, observing her. I assisted her to private vehicle. Advised mother to take pt to ER ASAP or PMD.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Chills, Cough, Decreased appetite, Fatigue
Clinical narrative: Tiredness'fatigue. Loss of appetite/weight loss. Chills. Nausea. Thigh/upper arm weakness. Cough. Sore muscles.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Muscular weakness, Myalgia, Nausea, Weight decreased
Clinical narrative: Tiredness'fatigue. Loss of appetite/weight loss. Chills. Nausea. Thigh/upper arm weakness. Cough. Sore muscles.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Pallor
Clinical narrative: Woke at 11AM crying, pale twice gave TYLENOL. 4 PM act fine except nursing fair. 9 AM next day - baby fine.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site (R) upper arm. Swelling noticed 8-2-15. Patient complains of pain and warmth at site, off and on. Started 5 days after injection. Seen in office today.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Musculoskeletal pain
Clinical narrative: Severe swelling and pain of shoulder, symptoms were somewhat improved but still persistent 1 week after.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Peripheral swelling, Skin warm
Clinical narrative: Large local reaction. Swelling, redness, warmth of deltoid.
Age: 66.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Got vaccine this am. Within a few hours developed pain and swelling at injection site. Also got flu shot in other arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local swelling, Skin warm
Clinical narrative: After 24 hrs pt. states area got large red and hard, everyday it kept getting bigger came in on 10-5-15 PM the area was 2 x 7" red and warm and raised.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt and mother reports pt awoke at 3:00 AM morning after vaccination w/ MENACTRA. Fever of 102.7 and redness and severe swelling of injection site. Pt and mother report site swollen 4-5 inches in diameter. MOTRIN 600mg by mouth administered. Visit to RN at Health dept at 1 pm on 10/6/15 advised pt to continue ice packs to area, continue alternating TYLENOL and MOTRIN every 4 hours and give patient BENADRYL for itching. Called pt at 3:30 - per mother patient resting w/ slight improvement.
Age: 1.03
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection reddened and swollen. Warm to the touch. Reddened area approximately 60 x 60 cm. No blistered or broken skin.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Dizziness, Headache, Injected limb mobility decreased, Injection site swelling
Clinical narrative: Headache, swelling of upper left arm, difficult to move arm and dizziness.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: None at time of vaccination. Developed rash 10/2015.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from the patient's husband and refers to her wife a female patient of unknown age. The patient's medical history, concurrent conditions and allergies were not reported. In approximately September 2015 (reported as "no enough one month"), the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. Then, in approximately September 2015, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were not reported. The pregnancy outcome was pending. The reporter wanted to know if there were any effects on the baby. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Muscle strain, Rash
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 68 year old female patient. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported). Co-suspect therapies or concomitant medications were not provided. Subsequently, within a few days of receiving the vaccination (date unspecified), the patient developed a rash on her shoulder. The patient was seen by an unspecified physician on an unspecified date and diagnosed with shingles and treated with VALTREX and ZOSTRIX. The patient was also seen at an unspecified hospital emergency room on an unspecified date, where she was diagnosed with muscle strain. However, it was unspecified if the patient was admitted to the hospital. The outcome of herpes zoster and muscle strain was unknown. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash, Tenderness
Clinical narrative: I had gotten a Shingles vaccination on Sept 28th at the clinic and within 3 days I started to get a rash and blisters on my left thigh. I found out that I now have shingles which comes along with the pain, tenderness and blister rash. Obviously I am not happy to contract something I took the time to prevent by having a vaccination for.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to two patients of unknown age and genders. Patients' medical history and concurrent conditions were not reported. On 01-OCT-2015 and on 02-OCT-2015, the patients were vaccinated with an improperly stored doses of VARIVAX (Merck) (lot #s L015046, expiry date 29-APR-2017 and L016125, expiry date 06-MAY-2017). No adverse effects were reported for any of these two additional unspecified patients. This is one of three reports from the same reporter source (MARRS linked cases 1510USA002521 and 1510USA002651). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to two patients of unknown age and genders. Patients' medical history and concurrent conditions where not reported. On 05-OCT-2015, the patients were vaccinated with an improperly stored doses of ZOSTAVAX (lot # L002424, expiry date 23-APR-2016). No adverse effects were reported for any of these two additional unspecified patients. This is one of three reports from the same reporter source (MARRS linked cases 1510USA002521, 1510USA002650). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to two patients of unknown age and genders. Patients' medical history and concurrent conditions were not reported. On 01-JAN-2015, the patients were vaccinated with an improperly stored doses of (Merck) PROQUAD (lot #s L019994, expiry date 02-DEC-2016 and L024124, expiry date 30-DEC-2016). No adverse effects were reported for any of these two additional unspecified patients. This is one of three reports from the same reporter source (MARRS linked cases 1510USA002650 and 1510USA002651). Additional information has been requested. Lot # L024124 is a valid lot # for (Merck) PROQUAD.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to an unspecified female patient of unknown age. No medical history and concurrent conditions of the patient were reported. On 26-NOV-2014, the patient was vaccinated with ZOSTAVAX (lot number, dose, site and route of administration was not reported) at the pharmacy. No concomitant medications were reported. On an unknown date, the patient experienced "goose-egg-size" hematoma at the vaccine injection site. The outcome of "goose-egg-size" hematoma was unknown. The causality of "goose-egg-size" hematoma with ZOSTAVAX was not reported. No further information was provided. This is one of the two reports of the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. No pertinent or historical conditions were reported. On 17-JUL-2015, the patient was vaccinated with GARDASIL (strength, dose and route unknown) and received a dose of GARDASIL 9 (strength, dose and route unknown) on 02-OCT-2015 in the office, which would be the second dose for the patient in the HPV series (interchange of vaccine products). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 10-SEP-2015 the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # L018001, expiration date: 19-MAY-2017, dose, route unspecified). Other suspect and concomitant therapies were not reported. No symptoms reported. The outcome of the event was unknown. This is on of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a female patient of unknown age. The patient's concurrent condition included multiple reactions to medications. On 09-MAR-2012, the patient was vaccinated with ZOSTAVAX vial at the pharmacy (lot number, dose, site and route of administration not reported). In March 2012 (reported as one week later), the patient developed zoster like rash and the patient was prescribed with VALTREX for approximately 3 months. The outcome of zoster like rash was unknown. The causality of zoster like rash with ZOSTAVAX was not reported. No further information was provided. No product quality complaint (PQC) was filed. This is one of the two reports of the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse and a healthcare worker referring to unspecified patients of unknown age and gender. In June 2015 (also reported as since 15-JUN-2015), the patients were vaccinated with doses of oral, ROTATEQ (lot # K017575, expiration date: 01-JUN-2016, oral, dose was unknown) which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unspecified date, in September 2015, reported as "sometime during the month of September 2015", the patients were vaccinated with unspecified improperly stored doses of PNEUMOVAX 23 lot #K008410 and expiration date 26-FEB-2016 and lot #L013428 expiration date 03-FEB-2017, (dose, route of administration and anatomical location were not provided). There were not concomitant medications reported. There was not product quality issue involved. This is one case of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unspecified date, in September 2015, reported as "sometime during the month of September 2015", the patients were vaccinated with unspecified improperly stored doses of MMR II lot # J013316 and expiration date 22-OCT-2015, lot # K022285 expiration date 12-NOV-2016, lot # L009213 expiration date 17-MAR-2017 and lot # K024035 expiration date 26-NOV-2016, (dose, route of administration and anatomical location were not provided). There were not concomitant medications reported. There was not product quality issue involved. This is one case of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates between July 2015 and 11-SEP-2015, these patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L010595, expiration date: 12-NOV-2016, strength, dose and route unknown) (incorrect product storage). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and allergies were not reported. On 01-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX, (strength, does, frequency, route and anatomical location were not reported), lot # L012475 with expiration date: 10-JUL-2016, which was improperly stored. No adverse effects were reported. Other suspect and concomitant therapies were not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Local swelling, Pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 65 year old female patient. The patient's medical history included unspecified blood pressure issues. On 18-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot# reported as L015417, expiration date: 01-AUG-2016) 1 vial, subcutaneously (frequency was unspecified). Concurrent medications included unspecified cholesterol medicines. On 18-SEP-2015, after the patient received ZOSTAVAX vaccination, a huge bump appeared from the injection site to the armpit (injection site mass) and she was in pain. No PQC was involved. It was stated that the patient sought for medical attention by calling the doctor. At the time of the report, the outcome of injection site mass and pain was reported as not recovered. The relatedness of ZOSTAVAX with injection site mass and pain was not reported. Additional information is not expected as the reporter did not wish further contact.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an 11 month 365 days old patient of unknown gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 11-DEC-2002 the patient was vaccinated with MMR II (strength, dose, frequency, route, lot #, expiry date unspecified). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a adult male patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult (batch number 3FZ74, expiry date unknown) and ENGERIX B adult (batch number 7S29F, expiry date unknown). On an unknown date, the patient received the 1st dose of ENGERIX B adult, the 2nd dose of ENGERIX B adult and the 3rd dose of ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult and ENGERIX B adult and 61 days after receiving ENGERIX B adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details provided were as follows: The registered nurse reported that, the patient completed a series of ENGERIX B adult vaccine on unspecified dates. On unknown date, 2 months after completing the vaccination series with ENGERIX B, the patient was tested negative for Hepatitis B surface antibody, causing the patient to be a non-responder to therapy. The reported batch number (3F274) for 2nd dose of ENGERIX B did not exist and was updated to 3FZ74 according to sales database. The reported batch number (7529F) for 3rd dose of ENGERIX B did not exist and was updated to 7S29F according to sales database as well. At the time of reporting, no further information was available.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site blisters in a 73-year-old female patient who received BOOSTRIX (batch number NL7K3, expiry date 15th September 2017). On 26th September 2015, the patient received the 1st dose of BOOSTRIX .5 ml. On 26 September 2015, less than a day after receiving BOOSTRIX, the patient experienced injection site blisters, diarrhea and headache. On an unknown date, the outcome of the injection site blisters, diarrhea and headache were not recovered/not resolved. It was unknown if the reporter considered the injection site blisters, diarrhea and headache to be related to BOOSTRIX.
Age: 20.0
Sex: F
Vaccine: VARZOS
Symptoms: Upper extremity mass
Clinical narrative: Information has been received from a pharmacist referring to a 20 year old female patient. On 11-SEP-2015 the patient was vaccinated with ZOSTAVAX (dose, strength unknown, lot # L003218, expiry date: 30-APR-2016) subdermally. On an unknown date in September 2015 the patient developed a large swollen mass on the back of her arm. The patient came into the pharmacy on 27-SEP-2015 and the mass was no longer on the back of the patient's arm. The events self-resolved on an unspecified date in September 2015. Causality between the event and the ZOSTAVAX was not provided. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unspecified date, in September 2015, reported as "sometime during the month of September 2015", the patient's were vaccinated with unspecified improperly stored doses of GARDASIL, lot # H021861 and expiration date 09-OCT-2015, lot # J008423 expiration date 21-JAN-2016 and lot # K010215 expiration date 05-MAY-2017, (dose, route of administration and anatomical location were not provided). There were not concomitant medications reported. There was not product quality issue involved. This is one case of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unspecified date, in September 2015, reported as "sometime during the month of September 2015", the patients were vaccinated with unspecified improperly stored doses of ROTATEQ, oral, lot # K013861 and expiration date 18-MAY-2016 and lot # K022990 expiration date 26-JUN-2016, (dose and anatomical location were not provided). There were not concomitant medications reported. There was not product quality issue involved. This is one of case of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple patients of unknown age and gender. On multiple unspecified dates the patients were vaccinated with improperly stored PROQUAD (Merck) (lot #: L019996, expiry date: 02-DEC-2016, lot #: L004007, expiry date: 15-APR-2016, lot#: L011079 (also reported as L0011079), expiry date: 01-OCT-2016) and VARIVAX (Merck) (lot # reported as L008273, expiry date: 11-MAR-2017, lot #: L001330, expiry date: 13-JAN-2017, lot #: L010146, expiry date; 24-MAR-2017, lot #: L000456, expiry date: 06-JAN-2017, lot #: L001330, expiry date: 13-JAN-2017). No adverse events were reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Drug administered at inappropriate site, Injection site injury, Insomnia, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: (Vaccination was given too high on shoulder. Caused shoulder injury). Urgent care visit, Rxs. Orthopedic visit with shoulder injections, Physical Therapy, MRI. Comes to clinic today as a new patient with complaints of left shoulder pain. Was asymptomatic prior to a DTP injection October 1, 2014. Received the injection from pharmacy. States the injection was given high in the shoulder. Since injection she's had severe left shoulder pain with restricted range of motion. Dr. ordered an MRI of the shoulder, she had a shoulder injection with only temporary relief. Here today for further evaluation. Severe pain and restricted motion left shoulder. Has difficulty sleeping at night. Shoulder: Comes to clinic today for follow up visit concerning her left shoulder. Was asymptomatic prior to a DTP injection October 1, 2014. Received the injection from pharmacy. States the injection was given high in the shoulder. Since injection she's had severe left shoulder pain with restricted range of motion. Dr. ordered an MRI of the shoulder, she had a shoulder injection with only temporary relief. Last time I injected the shoulder which was December 11 2014 she got great relief for couple weeks. She participated in self-directed therapy but now starting to get recurrent pain and having moderate to severe pain with significant loss of motion. Has difficulty sleeping at night. Previous MRI demonstrated rotator cuff tendinopathy and tear of the posterior quadrant of the glenoid labrum. However her pain seems to be mainly lateral and anterior.
Age: 53.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: (Vaccination was given too high on shoulder. Caused shoulder injury). Urgent care visit, Rxs. Orthopedic visit with shoulder injections, Physical Therapy, MRI. Comes to clinic today as a new patient with complaints of left shoulder pain. Was asymptomatic prior to a DTP injection October 1, 2014. Received the injection from pharmacy. States the injection was given high in the shoulder. Since injection she's had severe left shoulder pain with restricted range of motion. Dr. ordered an MRI of the shoulder, she had a shoulder injection with only temporary relief. Here today for further evaluation. Severe pain and restricted motion left shoulder. Has difficulty sleeping at night. Shoulder: Comes to clinic today for follow up visit concerning her left shoulder. Was asymptomatic prior to a DTP injection October 1, 2014. Received the injection from pharmacy. States the injection was given high in the shoulder. Since injection she's had severe left shoulder pain with restricted range of motion. Dr. ordered an MRI of the shoulder, she had a shoulder injection with only temporary relief. Last time I injected the shoulder which was December 11 2014 she got great relief for couple weeks. She participated in self-directed therapy but now starting to get recurrent pain and having moderate to severe pain with significant loss of motion. Has difficulty sleeping at night. Previous MRI demonstrated rotator cuff tendinopathy and tear of the posterior quadrant of the glenoid labrum. However her pain seems to be mainly lateral and anterior.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a healthcare professional (nurse) on 20 April 2015. An 11-year-old male patient whose medical history was not reported had received a dose of MENACTRA manufacturer: Sanofi Pasteur Inc (batch number, dose of vaccine and route of vaccination were not reported) in arm, a dose of TDAP manufacturer: unknown, (batch number, dose of vaccine and route of vaccination were not reported) in arm and 0.5 ml, first dose of GARDASIL intramuscularly in the opposite arm, manufacturer: other. All these vaccines were administered on 23 March 2015. On 23 March 2015, same day after vaccination patient experienced pain, warmth and swelling the size of soft ball at the injection site. Medical history and drug allergies of the patient were reported as none. Patient sought medical attention on 23 March 2015. The patient received unspecified corrective treatment. Lab investigation was reported as none. At the time of this report, the outcome of the patient was reported as unknown. Documents held by sender: none. Follow-up information received from nurse on 30 June 2015. Patient information was updated. Patient has medical history of ADHD (Attention Deficit Hyperactivity Disorder). Patient received CONCERTA as concomitant medications. Patient was received MENACTRA in left arm (batch number-U4986AA) and TDAP in left arm (batch number- U4971AA) and GARDASIL in right arm. Patient received these vaccines as first doses previously. Patient did not receive any vaccinations 4 weeks prior. Patient has no illness at the time of vaccination. Vaccine administered by was updated. Responsible physician contact information was updated. Patient was vaccinated at private doctor's office/hospital and vaccine purchased at public funds. It was reported that reaction was decreased. It was decided to continue with HPV 2. Patient was premedicated with BENADRYL before HPV 2 and took ZYRTEC for 3 days after which there was no redness, swelling and discomfort was noted with second dose. At the time of this report, it was reported that pain, redness and swelling subsided on 4 April 2015 and on unspecified date; patient was recovered from the event. List of documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a healthcare professional (nurse) on 20 April 2015. An 11-year-old male patient whose medical history was not reported had received a dose of MENACTRA manufacturer: Sanofi Pasteur Inc (batch number, dose of vaccine and route of vaccination were not reported) in arm, a dose of TDAP manufacturer: unknown, (batch number, dose of vaccine and route of vaccination were not reported) in arm and 0.5 ml, first dose of GARDASIL intramuscularly in the opposite arm, manufacturer: other. All these vaccines were administered on 23 March 2015. On 23 March 2015, same day after vaccination patient experienced pain, warmth and swelling the size of soft ball at the injection site. Medical history and drug allergies of the patient were reported as none. Patient sought medical attention on 23 March 2015. The patient received unspecified corrective treatment. Lab investigation was reported as none. At the time of this report, the outcome of the patient was reported as unknown. Documents held by sender: none. Follow-up information received from nurse on 30 June 2015. Patient information was updated. Patient has medical history of ADHD (Attention Deficit Hyperactivity Disorder). Patient received CONCERTA as concomitant medications. Patient was received MENACTRA in left arm (batch number-U4986AA) and TDAP in left arm (batch number- U4971AA) and GARDASIL in right arm. Patient received these vaccines as first doses previously. Patient did not receive any vaccinations 4 weeks prior. Patient has no illness at the time of vaccination. Vaccine administered by was updated. Responsible physician contact information was updated. Patient was vaccinated at private doctor's office/hospital and vaccine purchased at public funds. It was reported that reaction was decreased. It was decided to continue with HPV 2. Patient was premedicated with BENADRYL before HPV 2 and took ZYRTEC for 3 days after which there was no redness, swelling and discomfort was noted with second dose. At the time of this report, it was reported that pain, redness and swelling subsided on 4 April 2015 and on unspecified date; patient was recovered from the event. List of documents held by sender: None.
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Abdominal pain, Abortion spontaneous, Amniotic cavity infection, Exposure during pregnancy, Foetal death
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a patient (fetus). On 07-Nov-2014, the patient received Afluria (influenza virus vaccine polyvalent, batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: US-BEH-2015052681). The mother gave birth to a still born 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death. VAERS case ID: 574857. Follow up (23-Sep-2015): The health authority reported the terms abdominal pain, amniotic cavity infection, delivery, heart rate increased, hypertension, muscle spasms, premature labour and still birth (NB: In context, the events belong to the mother - see US-BEH-2015052681). The patient attended the Emergency Room. Reporter's Comments: VAERS case ID: 574857. Sender's Comments: Seriousness: Serious.  Fetal death. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, Pneumonia and foetal death is unlisted. Maternal drug exposure is listed as vaccination is not contraindicated in pregnancy. Causality: Not related. The time to foetal demise is not clear but approximately within days following vaccination in mother.  The maternal diagnosis was chorioamnionitis and Pneumonia in foetus which is possibly due to amniotic infection. The origin of (maternal) infection is not known but infection from vagina, colon and or urinary tract infection are plausible as opposed to vaccination. Company assessment 05-Oct-2015:  No change in assessment.
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Foetal disorder, Heart rate increased, Hypertension, Laboratory test abnormal, Muscle spasms
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a patient (fetus). On 07-Nov-2014, the patient received Afluria (influenza virus vaccine polyvalent, batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: US-BEH-2015052681). The mother gave birth to a still born 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death. VAERS case ID: 574857. Follow up (23-Sep-2015): The health authority reported the terms abdominal pain, amniotic cavity infection, delivery, heart rate increased, hypertension, muscle spasms, premature labour and still birth (NB: In context, the events belong to the mother - see US-BEH-2015052681). The patient attended the Emergency Room. Reporter's Comments: VAERS case ID: 574857. Sender's Comments: Seriousness: Serious.  Fetal death. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, Pneumonia and foetal death is unlisted. Maternal drug exposure is listed as vaccination is not contraindicated in pregnancy. Causality: Not related. The time to foetal demise is not clear but approximately within days following vaccination in mother.  The maternal diagnosis was chorioamnionitis and Pneumonia in foetus which is possibly due to amniotic infection. The origin of (maternal) infection is not known but infection from vagina, colon and or urinary tract infection are plausible as opposed to vaccination. Company assessment 05-Oct-2015:  No change in assessment.
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Pathology test, Premature labour, Stillbirth
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a patient (fetus). On 07-Nov-2014, the patient received Afluria (influenza virus vaccine polyvalent, batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: US-BEH-2015052681). The mother gave birth to a still born 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death. VAERS case ID: 574857. Follow up (23-Sep-2015): The health authority reported the terms abdominal pain, amniotic cavity infection, delivery, heart rate increased, hypertension, muscle spasms, premature labour and still birth (NB: In context, the events belong to the mother - see US-BEH-2015052681). The patient attended the Emergency Room. Reporter's Comments: VAERS case ID: 574857. Sender's Comments: Seriousness: Serious.  Fetal death. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, Pneumonia and foetal death is unlisted. Maternal drug exposure is listed as vaccination is not contraindicated in pregnancy. Causality: Not related. The time to foetal demise is not clear but approximately within days following vaccination in mother.  The maternal diagnosis was chorioamnionitis and Pneumonia in foetus which is possibly due to amniotic infection. The origin of (maternal) infection is not known but infection from vagina, colon and or urinary tract infection are plausible as opposed to vaccination. Company assessment 05-Oct-2015:  No change in assessment.
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Abdominal pain, Abortion spontaneous, Amniotic cavity infection, Foetal death, Heart rate increased
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a patient (fetus). On 07-Nov-2014, the patient received Afluria (influenza virus vaccine polyvalent, batch number T52208) via the mother, in-utero. On 08-Nov-2014, the patient's mother experienced leg cramps and abdominal pain and was in pre-term labor. The mother also had extremely high blood pressure and rapid heart rate upon arriving at the entrance of the ER (emergency room) (refer to case: US-BEH-2015052681). The mother gave birth to a still born 16-weeks gestation baby. The pathology of the placenta and fetus revealed chorioamnionitis of the placenta and the fetus patient developed pneumonia, which resulted in fetal death. The outcome was fetal death. VAERS case ID: 574857. Follow up (23-Sep-2015): The health authority reported the terms abdominal pain, amniotic cavity infection, delivery, heart rate increased, hypertension, muscle spasms, premature labour and still birth (NB: In context, the events belong to the mother - see US-BEH-2015052681). The patient attended the Emergency Room. Reporter's Comments: VAERS case ID: 574857. Sender's Comments: Seriousness: Serious.  Fetal death. Listedness: Unlisted. According to the CSL Inactivated Influenza Virus Vaccine CCDS, all events are unlisted. According to the Afluria PI, Pneumonia and foetal death is unlisted. Maternal drug exposure is listed as vaccination is not contraindicated in pregnancy. Causality: Not related. The time to foetal demise is not clear but approximately within days following vaccination in mother.  The maternal diagnosis was chorioamnionitis and Pneumonia in foetus which is possibly due to amniotic infection. The origin of (maternal) infection is not known but infection from vagina, colon and or urinary tract infection are plausible as opposed to vaccination. Company assessment 05-Oct-2015:  No change in assessment.