chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 22-JUL-2016, the patient was vaccinated subcutaneously with an expired 0.5 ml dose of VARIVAX (Lot # K010442, expiry date 22-JUL-2016). No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patient's medical histories and concurrent conditions were not provide. On unknown dates, the patient were vaccinated with VARIVAX (dose and routed were unknown, lot # L001330, expiration date 13-JAN-2017; lot # L028278, expiration date 28-JUL-2017; lot # L043624, expiration date 03-NOV-2017 and lot # was reported as L048466, expiration date 02-DEC-207). The nurse provided the details of excursion: temperature max of -7.2 degree centigrade for a cumulative time frame of 9 hours and 17 minutes and a max of -12.6 degree centigrade for cumulative time frame of 6 hours an 10  minutes. The current temperature was -14.1 degree centigrade, which was still out of range at the time of the report. The vaccines were also exposed to a previous excursion of -4 degree centigrade for 3 hours. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.4
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. The patient received 2 dose of M-M-R II injection (dose and route unknown) separately at 13 months and 17.5 months of age (product use issue). No adverse symptom was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report received from a pharmacy intern refers to three unspecified pediatric patients of unknown age and gender. Information on patients pertinent medical history and drug reactions/allergies were not reported. The pharmacy intern reported that three unspecified pediatric patients received adult formulation doses of RECOMBIVAX HB (lot number and expiration date not reported) on 19-JUL-2016 and 20-JUL-2016. No adverse effects were reported. No further details are given. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event, Overdose
Clinical narrative: This spontaneous report as received from a Nurse refers to a patient of unknown demography. On 28-JUL-2016, the patient was vaccinated with RECOMBIVAX HB (strength: 5/0.5 microgram/ml) (lot was unknown), intramuscular and on the same day, the patient was also vaccinated with PEDIARIX at an unknown injection site (Overdose and inappropriate schedule of drug administration). No adverse effects reported. No further information provided. No PQC involved. Additional information had been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator (immunization coordinator0 and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unspecified date after 10-JUL-2016, the patients were vaccinated with improperly stored doses of VARIVAX lot # L013067 (dose, route of administration, anatomical location and expiration date were not provided). The vaccine was exposed to 9.1 degrees Fahrenheit for 1 hour. There was no previous excursion. The call was made because of a "data logger". The outcome of excursion was reported as "supported". No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Initial solicited report received from a partner on 05 October 2015 from a consumer in a study. The subject (gender and age were not reported) received a dose of INFLUENZA VACCINE (date of vaccination, site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. On an unspecified date the subject had a reaction after vaccination. The subject was informed by a pharmacist that "it was the same vaccine", only it takes effect quicker than regular. The subject had taken Flu vaccine ever since it became available (over 30 years) and the high dose vaccine was the only vaccine the subject had a reaction to. "Information on side effects and is it really effective". The lab data and corrective treatment details were not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Initial solicited report received from a consumer in a study on 05 October 2015. The subject (gender and age were not reported) received a dose of INFLUENZA VACCINE (date of vaccination, site and route of administration and batch number were not reported, manufacturer unknown). Medical history and concomitant therapies details were not reported. The subject felt sick on an unspecified date, after taking a dose of vaccine previously. The subject was about to take a decision if it was safe to try it again and then would seek that out. The lab data and corrective treatment details were not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: Initial unsolicited report received from nurse on 12-Oct-2015. This case was linked to 2015SA161942 (same reporter). This case involves a patient (age and gender was not reported) who was vaccinated with an intradermal dose of Fluzone QIV (batch number, expiry date and site of administration were not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date, after vaccination, patient developed Weakness, numbness and pain in the arm that was injected. Lab test and corrective treatments were not reported. At the time of report, outcome of the events was not reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Rash macular, Skin warm
Clinical narrative: Based on additional information received on 13 December 2015, this report previously considered as non-valid become valid as patient's identifiers were reported. Initial unsolicited report received from a pharmacist on 08 October 2015. This is an invalid case as no patient identifiers were reported. It was reported that Fluzone HD (batch number, dose, dose in series, route and site of administration were not reported) was administered on an unspecified date. Medical history and concomitant medication was not reported. On an unspecified date, following vaccination, the patient experienced adverse event which was not specified. Laboratory investigation and corrective treatment was not reported. At the time of this report, the outcome of the event was not reported. Follow-up information received from a pharmacist on 13 December 2015. The patient was vaccinated with Fluzone HD (batch number: UI44804) in left upper arm. Any other vaccination within 4 weeks prior to vaccination was reported as none. On an unspecified date, following the vaccination, the patient had developed warm, red blotches. The patient was recovered from the events (within 5-7 days). List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a nurse via other pharmaceutical company (Pfizer) on 13 October 2015. This case involves a female (age not reported) patient who was vaccinated with a dose of FLUZONE (batch number, expiration date, dose, dose number, route and site of administration were not reported) and a dose of Flu shot on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date following the vaccination (with Flu shot), the patient developed some adverse reaction to thimerosal with the preservative that she had got with the flu shot in the past and on an unspecified date following the vaccination with FLUZONE, the patient developed swelling in arm. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none. Follow up information received from a nurse on 20 November 2015. On an unspecified date, following the vaccination patient experienced erythematous reaction and reaction with the Flu shot preservative. Outcome of event was not reported. Follow up information received from nurse on 17 February 2016. It was reported that patient had adverse event with previous Influenza vaccination.
Sex: F
Vaccine: FLU3
Symptoms: Myelitis
Clinical narrative: Initial unsolicited report received from a consumer on 14 October 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed myelitis. Laboratory data and corrective treatment were not reported. The outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: myelitis. List of documents held by sender: none.; Sender's Comments: Listed event Myelitis following INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE administration. Time to event onset, patient demographics, medical and family history, concurrent medication, investigative details etc. would help assess the case better. Based on the information provided, the case cannot be completely assessed.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Initial unsolicited report received from a pharmacist on 14 October 2015. This case involves a 72-years-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI459AB, expiry date: 30 April 2016, dose, dose in series, were not reported) intramuscularly in left deltoid on 11 September 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergic to milk, cheese, slight sensitivity to eggs. The patient had previously received flu vaccines with no previous reactions. Concomitant medications were not reported. On 12 September 2015, one day following the vaccination, the patient had experienced pain in shoulder area of left arm which continued till today (14 October 2015). It was reported that the pain is a sharp pain and keeps her awake at night. Relevant diagnostic tests/laboratory data and corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray limb normal
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 15 October 2015. This case involves a (44-year-old) female patient who was vaccinated with a intramuscular [dose series not reported] dose of FLUZONE QIV NP (batch number UI444AA, expiry date 30 June 2016) in left deltoid on 24 September 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Concomitant medications was not reported. On 25 September 2015, one day following the vaccination patient experienced pain, limited range of motion (ROM) and problems moving left arm day. On an unspecified date the patient had left shoulder pain. It was reported that, patient was evaluated by her child's pediatrician. Patient was re-evaluated by her own physician who ordered a left (L) shoulder x-ray which was negative and may possibly had an magnetic resonance imaging (MRI). It was reported that, patient required emergency room (ER)/doctor visit. Corrective treatment was Ibuprofen three times a day and a medrol pack. Patient reported left shoulder pain came back post medrol pack. The outcome of event was unknown. List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited report received from a consumer on 14 October 2015. This case involves a 61-Year-Old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, route and site of administration, dose in series were not reported) on unspecified date on Sunday. Patient had medical history of feeling ill which were flu like symptoms after taking Avonex. The patient was also taking TERIFLUNOMIDE (Aubagio) 14 mg orally daily since 24 September 2015 as concomitant medication for multiple sclerosis. On an unspecified date after vaccination on Monday, the patient was feeling ill. The patient's laboratory data was not reported. The patient received corrective treatment with Ibuprofen. The patient was recovered from the event on an unspecified date. List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, Headache, Pain in extremity, Rhinorrhoea, Sneezing
Clinical narrative: Initial unsolicited misuse report received from a pharmacist on 15-Oct-2015. This case involves a patient, who was vaccinated twice with Flu vaccine (manufacturer: unknown, batch number, route and site of administration were not reported) on an unspecified date. It was an overdose vaccine administration. No adverse event was reported. Follow up information received from a pharmacist on 21 December 2015. The patient's identifiers was updated. This case involves a 65-year-old female patient who was vaccinated with a dose of FLUVIRIN (batch number: 1514621, manufacturer: Novartis) intramuscularly in right arm and with a dose of FLUZONE HD (batch number: UI453AA) intramuscularly in left arm on 14 October 2015 at 11:45 AM. The patient vaccinated with a first dose of PREVNAR 13 (batch number: H86652, manufacturer: Pfizer) intramuscularly in left arm on 29 October 2015. Illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and adverse event following prior vaccination were reported as none. On 15 October 2015, one day following the vaccination, the patient had developed sore arm, no redness, no swelling and mild headache. On 19 October 2015, five days following the vaccination, the patient had sneezing and runny nose. The patient was not seen by MA following administration. On an unknown date, the patient was recovered from all the events. Documents held by sender: none.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site pain
Clinical narrative: Initial unsolicited report received from a non-health care professional (pharmacy manager) on 16 October 2015. This case involves a 72-year-old male patient, who was vaccinated with second dose of  FLUZONE HD (batch number: UI477AA, Expiry date: 20 May 2016) (dose and route of administration was not reported) in left deltoid on 01 October 2015. The patient had received previous dose of FLUZONE HD on an unspecified date. It was reported that patient had no illness at the time of vaccination. Medical history and concomitant medications were not reported. It was also reported that patient had no known allergies. On 01 October 2015, same day following vaccination, the patient had bleeding at the site. On  unspecified date, patient had experienced pain and quarter size bruise at the injection site. It was reported that no laboratory investigations were performed and corrective treatment was not reported. At the time of this report, the patient was not recovered from the events. Documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration
Clinical narrative: Initial unsolicited report received from a physician on 16 October 2015. This case involves a 64-year-old female patient who was vaccinated with a second dose of FLUZONE (batch number UI493AA, expiry date and route of administration were not reported) in left deltoid on 15 October 2015. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was no known allergy (NKA). Patient had no vaccinations within 4 weeks of vaccinations. On 15 October 2015, few seconds "immediately" following the vaccination patient experienced redness and induration at the site of a few inches. Patient had no laboratory investigation. Corrective treatment was ice. The outcome of event was recovered. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Local reaction
Clinical narrative: Initial unsolicited report received from a nurse on 15 October 2015. This case was linked with 2015SA164323 and 2015SA165706. This case involves a patient (age, gender not reported), who was vaccinated with first dose of FLUZONE QIV (batch number: UI444AB expiry date: 30 June 2016) (dose and site of administration was not reported) via intramuscular route on 14 October 2015. The patient had no illness at the time of vaccination and no pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medication was not reported. On 14 October 2015, few hours after vaccination, patient experienced larger local reaction which was greater than 5 inches. It was reported that patient required ER/doctor visit. No laboratory investigations were performed and patient was requested to be reviewed by the primary care doctor and considered antibiotics as corrective treatment. At the time of this report, patient had not recovered from the events. Documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal pain, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a health care professional (Infectious Disease Specialist) on 28 October 2015. This case involves a 40 years old female patient whose was vaccinated with a dose of FLUZONE HD (batch number, dose, dose number and site were not reported) via intramuscular route on 2 October 2015. Patient's medical history includes allergies to antibiotics: Penicillin, erythromycin and concomitant medications was not reported. It was reported that, on 2 October 2015 (same day after vaccination in evening) patient developed severe pain in her arm, shoulder, and neck and also progressed to include headache, myalgia, low grade temp, sinusitis. It was reported that the patient required ER/doctor visit. Lab data and corrective treatment were not reported. The outcome of the events pain in arm, shoulder, neck, headache, myalgia, low grade temp and sinusitis were recovering at the time of this report. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Sinusitis, Wrong drug administered
Clinical narrative: Initial unsolicited report received from a health care professional (Infectious Disease Specialist) on 28 October 2015. This case involves a 40 years old female patient whose was vaccinated with a dose of FLUZONE HD (batch number, dose, dose number and site were not reported) via intramuscular route on 2 October 2015. Patient's medical history includes allergies to antibiotics: Penicillin, erythromycin and concomitant medications was not reported. It was reported that, on 2 October 2015 (same day after vaccination in evening) patient developed severe pain in her arm, shoulder, and neck and also progressed to include headache, myalgia, low grade temp, sinusitis. It was reported that the patient required ER/doctor visit. Lab data and corrective treatment were not reported. The outcome of the events pain in arm, shoulder, neck, headache, myalgia, low grade temp and sinusitis were recovering at the time of this report. List of documents held by sender: none.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Muscle spasms, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Patient received Tdap vaccine in clinic on 7/19/16. Patient seen at hospital at 1550 on 7/20/16. She had c/o lower leg muscle weakness/leg pain and "constant Charlie horse" since the morning of 7/20/16. Hospital diagnosed her with paresthesia. Patient was offered admission and refused. Seen in clinic 7/26 with no c/o muscle weakness at this time.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Headache, Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Redness, itching, tingling, numbness, headache. Had a visible red bump at injection site with surrounding redness.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Redness, itching, tingling, numbness, headache. Had a visible red bump at injection site with surrounding redness.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: States she had severe arm pain following vaccination.  Reported it to us by e-mail 12/2/2015; did not return multiple phone calls.  We advised a physician evaluation and do not know if she went.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever measured at 100.6.
Age: 3.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: No adverse event just wrong immunization administered for age of child.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: States Left arm painful when lifting overhead, intermittent lasted through May 2016.
Sex: U
Vaccine: MMR, VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 27-JUL-2016, the patient was indicated to received M-M-R II and VARIVAX. Instead the patient was inadvertently administered with a dose of ZOSTAVAX injection, lot # M001747, expiry date 07-APR-2016 (does, route of administration and anatomical location were not specified) with the intended dose of VARIVAX injection, lot # M002064, expiry date 12-JAN-2016 (dose, route of administration and anatomical location were not provided). The nurse stated that since her facility stores all of the mentioned vaccines in the freezer, she simply took out a dose of ZOSTAVAX instead of a dose of M-M-R II. Once the error was discovered, the patient was also vaccinated with the intended dose of M-M-R II injection, lot # M002419, expiry date 12-JAN-2016 (dose, route of administration, anatomical location and therapy type were not reported) on the same day. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: None stated.
Age: 5.0
Sex: M
Vaccine: MMRV, VARCEL, MMR, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This happened this morning. We will follow up with parent. No adverse reaction at this moment.
Age: 5.0
Sex: M
Vaccine: MMRV, VARCEL, MMR, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This happened this morning. We will follow up with parent. No adverse reaction at this moment.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray limb normal
Clinical narrative: Pain in left arm where injection was given. Cannot lift arm associated with pain since date of injection. Patient sent for physical and occupational therapy. X-ray is normal. PT/OT without relief. Prescribed Celebrex and given orthopedic referral on 6/15/2016.
Age: 1.26
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Pallor, Rash, Rash papular
Clinical narrative: Erythematous papular blanching rash that blanches and is not painful. Distribution: started on face, trunk and arms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Area where vaccine given is red, swollen and warm to touch. Redness and swelling has continued to spread and get bigger since receiving the vaccine. No c/o fever or SOA. Pt has put some ice on the area but no other treatments at this time.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Redness and swelling at injection site in the morning. Hives developed in the afternoon on his face. Hives treated with BENADRYL.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt had swelling, redness and pain to the injection site. Pt was advised to apply ice to site and take MOTRIN for pain. Pt advised to call if site gets any worse.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Redness, swelling, large knot along arm where vaccine was injected. Lasted for approx. 3 weeks. Was given BENADRYL and cream recommended by RPh at different location. Condition has improved.
Age: 17.0
Sex: F
Vaccine: HPVX, MEN, MENB
Symptoms: Decreased appetite, Fatigue, Immediate post-injection reaction, Injected limb mobility decreased, Weight decreased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injected limb mobility decreased in a 17-year-old female patient who received BEXSERO (batch number 154101A, expiry date 30th May 2017). Concomitant products included HPV vaccine and Men ACWY-CRM NVS (potential MENVEO). On 15th July 2016, the patient received BEXSERO .5 ml. On 15th July 2016, immediately after receiving BEXSERO, the patient experienced injected limb mobility decreased (serious criteria disability), fatigue (serious criteria disability), appetite lost (serious criteria disability) and weight loss (serious criteria disability). In July 2016, the outcome of the injected limb mobility decreased was recovered/resolved. On an unknown date, the outcome of the fatigue, appetite lost and weight loss were recovering/resolving. The reporter considered the injected limb mobility decreased, fatigue, appetite lost and weight loss to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The doctor reported that the patient experienced inability to raise injected arm (right deltoid) immediately following BEXSERO vaccination for 1 week. On the same day, the patient also experienced fatigue, loss of appetite and weight loss of 6 pounds for 2 weeks after vaccination and they were ongoing at the time of reporting.
Age: 12.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Heart rate decreased, Hypotension, Loss of consciousness, Presyncope, Syncope
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of loss of consciousness in a 12-year-old female patient who received BEXSERO (batch number 156801, expiry date 31st August 2017). Concurrent medical conditions included anxiety. Concomitant products included GARDASIL 9. In July 2016, the patient received the 1st dose of BEXSERO 1 ml. In July 2016, 1 min after receiving BEXSERO, the patient experienced loss of consciousness (serious criteria GSK medically significant) and syncope vasovagal. In July 2016, the outcome of the loss of consciousness and syncope vasovagal were recovered/resolved. The reporter considered the loss of consciousness and syncope vasovagal to be unlikely related to BEXSERO. Additional details were provided as follows: This case was reported by an office manager. The patient received both the vaccines on the same day in her arms. The patient experienced an episode of syncope and vasovagal reaction (loss of consciousness, low blood pressure and heart rate) after receiving BEXSERO. The patient did not sustain any injury. She was monitored in the office for 30 minutes following the event and sent home with no sequelae. The vaccination date was unclear, it could be 26th or 27th July 2016. This was the second or third dose of HPV vaccine. The other healthcare professional felt that the events were due to anxiety and not due to vaccines.
Age: 0.1
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 19 week old patient. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date, at the age of 19 weeks, the patient was vaccinated with the first dose of ROTATEQ 2 ml, oral (lot # and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Mass
Clinical narrative: Initial unsolicited misuse report received from a non healthcare professional on 15-Oct-2015. This case is linked with case: 2015SA164145 (same reporter, same vaccine, same lot number). This case involves a patient (age and gender was not reported), who was vaccinated with a dose of FLUZONE QIV (manufacturer: Sanofi Pasteur, batch number: U5319AA, expiry date: 30-Jun-2016) given below deltoid, it was reported that it administered maybe via subcutaneous route on an unspecified date on 12-Oct-2015 or 13-Oct-2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Concomitant medications were not provided. On an unspecified date on 12-Oct-2015 or 13-Oct-2015, post vaccination; the patient developed a "grapefruit sized" lump. It was reported that patient maybe given vaccine via subcutaneous route which led to inappropriate route of vaccination Laboratory investigations and corrective treatment were not reported. It was reported that the patient required ER/doctor visit. The outcome of the event was reported as not recovered. Follow up information received from a non-healthcare professional on 16-Oct-2015. The patient gender was reported as female. It was reported that the patient went to physician for treatment and was advised, that she needed to be exempted from getting vacation next year. Documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Skin warm
Clinical narrative: Initial unsolicited report received from a pharmacist  on 15 October 2015. This case involves a 5-year-old male patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI444AA, expiration date: 30 June 2016, expiration date and dose not reported) given intramuscularly on left deltoid on 13 October 2015. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Previously patient received a dose of Influenza quadrival A-B vaccine on an unspecified date. Concomitant medication was not reported. On 14 October 2015, one day following the vaccination, the patient developed rash which was warm to touch. According to the patient's mother, the size of a post it note warm to touch (looks like a rug burn). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Discomfort, Local swelling, Skin warm
Clinical narrative: Initial unsolicited report received from a nurse on 15 October 2015. This case was linked to 2015SA165705 and 2015SA165706 (same vaccine, different events). This case involves 10 patients (age and gender not reported) who was vaccinated with first dose of FLUZONE QIV (batch number: UI444AB, Expiry date: 30 June 2016, dose, site of administration were not reported) intramuscularly on 14 October 2015. The patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within 4 weeks of vaccinations were reported as none. Concomitant medications were not reported. On 14 October 2015, few hours following the vaccination, the patient had developed 3 to 4 inch raised red hot area and had discomfort. Laboratory data was not reported. The patients were prescribed antibiotics, cold compress and OTC medications. The patient was not recovered from the events. List of documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLU3, TTOX
Symptoms: Insomnia
Clinical narrative: Initial unsolicited report received from a consumer on 19 October 2015. This case involves a 59-year-old female patient who was vaccinated with a dose of FLUZONE intramuscularly (batch number was unknown, dose, dose in series were not reported) in left deltoid and a dose of TETANUS TOXOID (batch number, dose, dose in series, route and site of administration were not reported) both vaccines on 17 October 2015. Six months ago the patient had history of thyroid ablation and was on medication. Illness at time of vaccination was unknown. The patient had allergies to iodine, nuts, shellfish, fruits, red dye. Concomitant medications were not reported. On 17 October 2015, same day following the vaccination, the patient experienced sleep difficulty. Lab data and corrective treatments were not reported. The patient was not recovered from the event. List of documents held by sender: none.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Condition aggravated, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Initial unsolicited report received from a consumer  on 18 October 2015. This case involves a 73-year-old male patient who was vaccinated with a dose of FLUZONE HD (lot number was unknown, dose in series, route and site of administration was not reported) on 7 October 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were unknown. Concomitant medications were not reported. On 7 October 2015, same day following the vaccination, the patient had aches, headaches, and had been tired and some numbness in his legs off and on. The patient did not see the physician. Lab data and corrective treatments were not reported. The patient was not recovered from the events. Follow-up information received from a physician on 22 December 2015 and 28 December 2015. It was reported that there was no illness at the time of vaccination except spinal stenosis and sciatica. Patient had medical history of spinal stenosis and sciatica. On an unknown date, patient experienced weakness and stated that the flu shot had made his condition worse especially tired and weak. Also reported that some of the problems had come from sciatica and spinal stenosis. No vaccine was administered within 4 weeks prior to date of vaccination. Laboratory data included x-ray of lumbar spine. On an unknown date patient recovered from all events. No further information was provided. List of documents held by sender: none.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Sciatica, Spinal X-ray, Spinal column stenosis
Clinical narrative: Initial unsolicited report received from a consumer  on 18 October 2015. This case involves a 73-year-old male patient who was vaccinated with a dose of FLUZONE HD (lot number was unknown, dose in series, route and site of administration was not reported) on 7 October 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were unknown. Concomitant medications were not reported. On 7 October 2015, same day following the vaccination, the patient had aches, headaches, and had been tired and some numbness in his legs off and on. The patient did not see the physician. Lab data and corrective treatments were not reported. The patient was not recovered from the events. Follow-up information received from a physician on 22 December 2015 and 28 December 2015. It was reported that there was no illness at the time of vaccination except spinal stenosis and sciatica. Patient had medical history of spinal stenosis and sciatica. On an unknown date, patient experienced weakness and stated that the flu shot had made his condition worse especially tired and weak. Also reported that some of the problems had come from sciatica and spinal stenosis. No vaccine was administered within 4 weeks prior to date of vaccination. Laboratory data included x-ray of lumbar spine. On an unknown date patient recovered from all events. No further information was provided. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: Initial unsolicited report received from a Nurse on 15 October 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced a reaction(unspecified). Laboratory data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia
Clinical narrative: Initial unsolicited report received from a pharmacist on 20 October 2015. This case involves a 70-year-old female patient who was vaccinated with a first dose of FLUZONE HD (batch number: UI442AA, expiration date: 6 April 2016, dose and route were not reported) in the right deltoid on 20 October 2015 at 12 noon. Illness at time of vaccination was none and patient had a history of high blood pressure, high cholesterol and no known allergies. Concomitant medications were not reported. On 20 October 2015, few hours following the vaccination, the patient called back to the pharmacy at 4 pm saying she was having difficulty swallowing. It was reported that her voice sounded fine. The patient required ER/Doctor visit. Laboratory investigations were reported none. The patient's corrective treatment includes Benadryl and she was advised to take medical treatment if not improved. The outcome of the event was reported as unknown. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Headache, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a physician  on 27 October 2015. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE (trivalent vaccine multi dose vial) (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not  reported. On an unspecified date, following the vaccination, the patient developed swollen painful arm, aching and headache. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients received unspecified doses of ROTATEQ immunization series, lot number L033545, expiration date: 30-MAY-2017, lot number L048854, expiration date: 31-AUG-2017 and lot number L035511, expiration date: 21-MAY-2017, orally, (does was not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 49.1 degrees Fahrenheit for 1 hour 7 minutes. The excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were 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: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 3 patients of unknown age and gender. In approximately 2016, the patient was vaccinated with ROTATEQ (dose: 2 ml, lot # L033694 with expiration date: 16-JUN-2017, lot # M012495 with expiration date: 09-OCT-2017 and lot # reported as M019708 with expiration date: 25-OCT-2017). The administered doses of ROTATEQ had a temperature excursion on 25-JUL-2016 48.6 for 65 hours and where unsupported. No adverse effects were reported. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 26 week old female patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of ROTATEQ, lot # M004508, orally, (dose and expiration date were not provided). There were no concomitant medications reported. The physician stated that the initial dose of ROTATEQ was administered when the child was 26 weeks old, that is later than the recommended start date for the vaccine. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected because the reporter did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 01-APR-2016, the patient was vaccinated with improperly stored dose of VARIVAX 9dose and route of administration were not reported, lot # K006133 with expiration date:29-APR-2016). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: Lightheadedness, drop in blood pressure (89/50). Patient had not eaten breakfast, so patient was made to lie down with feet elevated, observed, and assessed by a doctor in clinic. Patient's vital signs were monitored, and was given water. Blood pressure was stabilized to 100/60, and was released at 11:49 AM.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Cold sweat, Dyskinesia, Headache, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: After the HPV shot, she got an intense headache, we sat her down, she said her arm hurt. Them her head slumped, she kicked and flapped her arms a couple times. Her body got stuff and she wasn't conscious. We called 911. She regained consciousness, she complained of her throat hurting. She was very pale, clammy, and said her heart was racing. The paramedics came took all her vital signs and suggested we take her to her doctor, which we did immediately. They said fainting is a adverse reaction.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Oropharyngeal pain, Pain in extremity, Pallor, Palpitations, Posture abnormal
Clinical narrative: After the HPV shot, she got an intense headache, we sat her down, she said her arm hurt. Them her head slumped, she kicked and flapped her arms a couple times. Her body got stuff and she wasn't conscious. We called 911. She regained consciousness, she complained of her throat hurting. She was very pale, clammy, and said her heart was racing. The paramedics came took all her vital signs and suggested we take her to her doctor, which we did immediately. They said fainting is a adverse reaction.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a unspecified patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (dose and route of administration were not reported, lot # M003434, with expiration date: 19-JUL-2017). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received 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 concerning an unspecified number of patients of unknown gender and age was received from an office manager. The patient's concurrent conditions and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (strength and route were not provided), 3 doses of lot L042265, expiration date 26-OCT-2017 and 12 doses of lot M006722, expiration date 08-FEB-2018. There were no concomitant medications and adverse events reported. No product quality complain was involved. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood uric acid increased, Gout
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 63 year old patient. The patient had no pertinent medical history and drug reactions or allergies. On 29-JUL-2016, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot # and expiry date were not specified) to prevent shingles. Concomitant medication included unspecified eye drops. On 31-JUL-2016, the patient developed gout and increased uric acid level. The patient received treatment for the event (details were not specified). It was unknown if lab diagnostics studies were performed. The outcome of the events was reported as not recovered. The reporter did not provide the causality assessment. 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 nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX lot#M002063, expiry date: 12-JAN-2018 (dosing details was not reported). It was reported that the vaccines were exposed to the temperature of 24.3F during a time frame of 8 hours and 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.