chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. Between March and July 2016, possible several dosses of improperly stored (Oka/Merck) VARIVAX subcutaneously lot #s K021484, expiration date 03-NOV-2016, L019127, expiration date 27-MAY-2017 and L043624, expiration date 03-NOV-2017 may had been administered to unspecified patients. The datalogger had showed a minimum value of -13 Con multiple days between March and July 2016. The nurse could not confirm which lots might had been administered to the patients. No adverse effects had been reported. No product quality complain was involved. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with RECOMBIVAX HB lot # L044694, expiration date 04-FEB-2018 (route was not provided). Concomitant therapy information was not provided. On unknown dates, the patient received improperly stored doses of RECOMBIVAX HB. No adverse event was reported. At the time of the report, the patients' status was unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 62 year old female patient, who is also a Registered Nurse, referring herself. Concurrent conditions included allergy to aspirin (manufacturer unknown) (Captured in Regulatory reference # 1608USA005348) and epinephrine. There was no pertinent medical history. On 22-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX, via subcutaneous route, frequency reported as "once", (lot number L044530 and expiration date o 09-FEB-2017) (strength was not reported). Other suspect medications were not provided. There were no concomitant medications. On 28-JUL-2016, the patient experienced a rash on the right side of neck after receiving ZOSTAVAX, and the next day, on 29-JUL-2016, the rash spread further on back of the head and then jaw and ears. It was reported that the patient sought medical attention (unspecified) on an unknown date in 2016, and treatment with VALTREX and an unspecified pain medicine was given for the rash. Laboratory diagnostic studies were not performed. No product quality complaint was involved. At the time of reporting, the patient was recovering from the rash (also reported as the adverse event did not improve). The relatedness between the rash and therapy with ZOSTAVAX was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a 21 year old female patient reporting on herself. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot #, dose, frequency and route were not provided). Concomitant therapies were not provided. On an unknown date, the patient was unavailable to receive her second dose of GARDASIL due to temperature excursion as the patient picked up the vaccine from the pharmacy and was unable to store it properly before the schedule administration date. The incorrectly store vaccine was not administered. No further adverse event information was provided. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chest pain, Chills, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Fever, pain and swelling at site, chest pain, chills, fatigue.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pyrexia
Clinical narrative: Fever, pain and swelling at site, chest pain, chills, fatigue.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Pyrexia
Clinical narrative: Shortness of breath, chest pain unrelieved by nitroglycerin, fever. She went to hospital by ambulance where they did a full workup and couldn't find any reason except the vaccine for her symptoms.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Mononeuropathy, Muscular weakness, Neurological examination, Nuclear magnetic resonance imaging
Clinical narrative: Pt received a flu immunization 3/10/16 (R) deltoid area. Three days later developed (R) shoulder pain. He was seen in the ER and given MEDROL DOSE PACK and pain control. He was evaluated by O.T. therapy - MRI and neuro referral.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Winged scapula
Clinical narrative: Pt received a flu immunization 3/10/16 (R) deltoid area. Three days later developed (R) shoulder pain. He was seen in the ER and given MEDROL DOSE PACK and pain control. He was evaluated by O.T. therapy - MRI and neuro referral.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Cellulitis, Erythema, Injection site swelling, Lethargy
Clinical narrative: Temp up to 100, lethargic 8/16/16. Cellulitis, itching, redness, swelling to (R) deltoid. MENVEO injection site. 8/17/16
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pruritus
Clinical narrative: Temp up to 100, lethargic 8/16/16. Cellulitis, itching, redness, swelling to (R) deltoid. MENVEO injection site. 8/17/16
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash macular, Vomiting
Clinical narrative: Patient had diffuse erythematous macular rash with fever. Emesis x 1. Rash improving while on BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of right thigh after PROQUAD vaccination.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Full blood count normal, Neutrophil count increased, Petechiae, Platelet count normal
Clinical narrative: Mild Petechia on torso 3 days after DTAP, MMR, Varicella, HepA and PEV 13
Age: 7.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Wrong drug administered
Clinical narrative: Gave DTAP instead of Tdap.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Formication, Pruritus, Pruritus generalised
Clinical narrative: Severe itching - scalp - bumps - like bugs crawling - also palms of hands, feet, stomach - raised welt if scratched, stays red for hours. Burning feeling on toes. At times itched all over. Has subsided slowly over the year.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Severe itching - scalp - bumps - like bugs crawling - also palms of hands, feet, stomach - raised welt if scratched, stays red for hours. Burning feeling on toes. At times itched all over. Has subsided slowly over the year.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Sore arms after 11 days.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Movement disorder, Musculoskeletal pain
Clinical narrative: Patient had pain and limited movement in shoulder.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Screaming
Clinical narrative: After vaccine admin, mother reported that pt screamed for hours.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Confusional state, Crying, Hallucination, Mydriasis
Clinical narrative: Confusion, hallucinating, crying hysterically, pupils are dilated.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. Between March and July 2016, possible several doses of improperly stored ZOSTAVAX subcutaneously lot # L029482, expiration date 06-NOV-2016, may had been administered to unspecified patients. The data logger had showed a minimum value of -13 C on multiple days between March and July 2016. No adverse effects had been reported. No product quality complaint was involved. This is one two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Varicella vaccine storage temperatures were noted to be outside of recommended range. Due to inconsistencies in temperature documentation, the vaccine was deemed possibly ineffective. Patients have been notified.
Age: 42.0
Sex: M
Vaccine: RAB
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Neurological symptom
Clinical narrative: Initial unsolicited report received from the literature on 10-Aug-2016. This case was linked to 2016SA148381, 2016SA148766, 2016SA148787, 2016SA148792, 2016SA148885, 2016SA148897, 2016SA148890 AND 2016SA148892 (Same literature). The following is verbatim from the article: Abstract: Background: In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use. Objective: To assess adverse events (AEs) after HDCV reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods: We searched VAERS for reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barre© syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using Med-DRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results: VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions: This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. This case involves a 42 years male patient who was vaccinated with a dose of RABIES (HDC) VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient had no history of gastrointestinal or upper respiratory infections before being vaccinated. Patient's other medical history and concomitant medications were not reported. On unknown date, following the vaccination, the patient had Guillain-Barre Syndrome and presented varying neurological symptoms characterized mainly by increasing weakness, numbness and/or tingling in extremities and difficulty walking. Lab data and corrective treatment were not reported. The outcome of the events was not reported. Upon internal review the case was considered as serious because of important medical events: Guillain-Barre Syndrome. Documents held by sender: none. Sender's Comments: This case corresponds to literature article involving the patient with Guillain Barre syndrome following vaccination with RABIES (HDC) VACCINE. Guillain Barre syndrome is unlisted with the RABIES (HDC) VACCINE. Details such as patient's relevant medical history, prior vaccination history and tolerance, etc. are needed to further assess the role of vaccine. Based on the available information, no conclusion can be drawn.
Age: 42.0
Sex: M
Vaccine: RAB
Symptoms: Paraesthesia
Clinical narrative: Initial unsolicited report received from the literature on 10-Aug-2016. This case was linked to 2016SA148381, 2016SA148766, 2016SA148787, 2016SA148792, 2016SA148885, 2016SA148897, 2016SA148890 AND 2016SA148892 (Same literature). The following is verbatim from the article: Abstract: Background: In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use. Objective: To assess adverse events (AEs) after HDCV reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods: We searched VAERS for reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barre© syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using Med-DRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results: VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions: This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. This case involves a 42 years male patient who was vaccinated with a dose of RABIES (HDC) VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient had no history of gastrointestinal or upper respiratory infections before being vaccinated. Patient's other medical history and concomitant medications were not reported. On unknown date, following the vaccination, the patient had Guillain-Barre Syndrome and presented varying neurological symptoms characterized mainly by increasing weakness, numbness and/or tingling in extremities and difficulty walking. Lab data and corrective treatment were not reported. The outcome of the events was not reported. Upon internal review the case was considered as serious because of important medical events: Guillain-Barre Syndrome. Documents held by sender: none. Sender's Comments: This case corresponds to literature article involving the patient with Guillain Barre syndrome following vaccination with RABIES (HDC) VACCINE. Guillain Barre syndrome is unlisted with the RABIES (HDC) VACCINE. Details such as patient's relevant medical history, prior vaccination history and tolerance, etc. are needed to further assess the role of vaccine. Based on the available information, no conclusion can be drawn.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Muscle spasms, Sleep disorder, Tremor
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of muscle twitching in a 18-year-old female patient who received BEXSERO. Concomitant products included MENACTRA. On 12th July 2016, the patient received BEXSERO. On 12th July 2016, 30 min after receiving BEXSERO, the patient experienced muscle twitching (serious criteria other serious as per the reporter). The patient was treated with Steroids. On an unknown date, the outcome of the muscle twitching was unknown. It was unknown if the reporter considered the muscle twitching to be related to BEXSERO. Additional details were provided as follows: This case was reported by Director of Nursing (DON). The patient received BEXSERO and MENACTRA in separate arm but on the same day. The patient experienced generalized muscle twitching about 20 minutes after leaving the clinic on completion of the appointment. The patient did notify and see her physician. She was prescribed steroids. It was unknown when or if the issue was resolved, but it was noted that the issue progressively got worsened after the initial onset, which prompted the patient to visit the physician.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Muscle twitching
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of muscle twitching in a 18-year-old female patient who received BEXSERO. Concomitant products included MENACTRA. On 12th July 2016, the patient received BEXSERO. On 12th July 2016, 30 min after receiving BEXSERO, the patient experienced muscle twitching (serious criteria other serious as per the reporter). The patient was treated with Steroids. On an unknown date, the outcome of the muscle twitching was unknown. It was unknown if the reporter considered the muscle twitching to be related to BEXSERO. Additional details were provided as follows: This case was reported by Director of Nursing (DON). The patient received BEXSERO and MENACTRA in separate arm but on the same day. The patient experienced generalized muscle twitching about 20 minutes after leaving the clinic on completion of the appointment. The patient did notify and see her physician. She was prescribed steroids. It was unknown when or if the issue was resolved, but it was noted that the issue progressively got worsened after the initial onset, which prompted the patient to visit the physician.
Age: 27.0
Sex: F
Vaccine: HEPA
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hypoaesthesia, Musculoskeletal chest pain
Clinical narrative: Patient first said she felt dizzy and lightheaded.  Within 5 minutes, she said her fingers were tingling, face felt numb, and chest felt heavy.  Then she said her right rib cage area had extreme pain.  She said she was having difficulty breathing and was in pain.  911 had been called and firefighters then paramedics arrived and took her to ER.
Age: 27.0
Sex: F
Vaccine: HEPA
Symptoms: Paraesthesia
Clinical narrative: Patient first said she felt dizzy and lightheaded.  Within 5 minutes, she said her fingers were tingling, face felt numb, and chest felt heavy.  Then she said her right rib cage area had extreme pain.  She said she was having difficulty breathing and was in pain.  911 had been called and firefighters then paramedics arrived and took her to ER.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: Tired, fever, chills, mailais and extreame fatigue.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (0.65ml, subcutaneously, lot # L046295 with expiration date 17-FEB-2017), which exposed to temperature excursion (temperature: -1.2 degrees Celsius, time frame: 8 hours) because of data logger. There was no previous temperature excursion. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This prospective pregnancy report was received from a 33 year old female patient. On 26-JUN-2016, the patient was vaccinated with VARIVAX for prevention of varicella. The patient took TYLENOL once in a while. The patient received a confirmation she was pregnant on 17-JUL-2016. The patient sought medical attention via phone cell to physician. At the time of this report the patient was 4 weeks pregnant with LMP of 24-JUN-2016 and EDD of 31-MAR-2017. The pregnancy outcome was pending. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received call from patients mother who stated that child's left deltoid where DTAP-IPV was given was extremely red and swollen, mother directed to contact her child's pediatrician and to monitor the site and if child has any breathing issues to take her to ER right away. Mother stated that if she called pediatrician but they can not see her until next week, mother then was urged to take child to urgent care to be seen she v/u.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blood culture, Cellulitis, Erythema, Full blood count, Peripheral swelling
Clinical narrative: Swelling and redness to arm. Fever, cellulitis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Swelling and redness to arm. Fever, cellulitis.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to three unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of RECOMBIVAX HB (lot # M013639, expiration date: 15-SEP-2017) (dose and route of administration were not provided). No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture negative, Blood lactic acid normal, Cellulitis, Chest X-ray normal, Erythema
Clinical narrative: 53 yo male Hx COPD, bilat lobectomy 2015 x2; 56 py smoker, hx scarlet fever who received PPS23 vaccine at 14:30 on 30 June, 2016 and presented to ER at 20:30 with SVT, which was converted with adenosine and carotid sinus massage. Per chart review his WBC in ER was 14, ABS neuts 10.9; CXR WNL. the following day he experienced severe erythema, edema pain (no pruritus), from his shoulder to below elbow, was again seen in ER, and treated with septra and KEFLEX for cellulitis, which resolved in 2-3 days. ER WBC 13.7 ABS neuts 11.4. blood cultures neg; lactic acid, CMP WNL.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Metabolic function test normal, Neutrophil count normal, Oedema, Pain, Streptococcus test positive
Clinical narrative: 53 yo male Hx COPD, bilat lobectomy 2015 x2; 56 py smoker, hx scarlet fever who received PPS23 vaccine at 14:30 on 30 June, 2016 and presented to ER at 20:30 with SVT, which was converted with adenosine and carotid sinus massage. Per chart review his WBC in ER was 14, ABS neuts 10.9; CXR WNL. the following day he experienced severe erythema, edema pain (no pruritus), from his shoulder to below elbow, was again seen in ER, and treated with septra and KEFLEX for cellulitis, which resolved in 2-3 days. ER WBC 13.7 ABS neuts 11.4. blood cultures neg; lactic acid, CMP WNL.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: 53 yo male Hx COPD, bilat lobectomy 2015 x2; 56 py smoker, hx scarlet fever who received PPS23 vaccine at 14:30 on 30 June, 2016 and presented to ER at 20:30 with SVT, which was converted with adenosine and carotid sinus massage. Per chart review his WBC in ER was 14, ABS neuts 10.9; CXR WNL. the following day he experienced severe erythema, edema pain (no pruritus), from his shoulder to below elbow, was again seen in ER, and treated with septra and KEFLEX for cellulitis, which resolved in 2-3 days. ER WBC 13.7 ABS neuts 11.4. blood cultures neg; lactic acid, CMP WNL.
Sex: F
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Information has been from an unspecified healthcare worker from an office of the physician via a field representative concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient received PNEUMOVAX 23 injection (lot # expiry date, dose and route not provided). On an unknown date, the patient experienced adverse event and was taken to the emergency room. The nature of the adverse event could not be confirmed as of the time of this report. It could not be confirmed if the patient was still in the emergency room at the time of this report. It also could not be confirmed if the adverse event was life threatening or if any extraordinary means, such as oxygen or cardiopulmonary resuscitation (CPR), were necessary because of the adverse event. The outcome and causality of the adverse event was unknown. 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 nurse, referring to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with one dose of PROQUAD, which was improperly stored (lot number M007961 with expiration date of 15-AUG-2017) (strength, dosage schedule, route of administration and anatomical location were not reported). Other suspect and concomitant medications were not reported. No adverse effects were reported. The dose of the vaccine experienced a temperature excursion of -14.4 Celsius (C) for 2 hours and 54 minutes and it was reported that there was not previous temperature excursion. Furthermore, no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurse concerning an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (strength, dose, frequency and route unknown, lot # K000943, expiration date 24-SEP-2016; lot # L034381, expiration date 21-DEC-2016; lot # L018499, expiration date 25-FEB-2017). No adverse event was 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: M
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received form a pharmacist referring to a 39 year old male patient. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with pediatric dose of RECOMBIVAX HB (lot # L029631, expiration date 14-AUG-2017, strength unknown) intramuscularly (unapproved dose of administration). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with an improperly stored doses of PEDVAXHIB which had lot # L042257, expiry date 17-AUG-2018 and lot # L051123, expiry date: 13-OCT-2018 (strength, dose and route not reported). No adverse effect reported. No product quality complaint (PQC) involved. No further information reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: Information has been received from an office manager referring to a 12 years old male patient. The patient had no medical history, concomitant medication and drug reactions or allergies. On 20-JUL-2016, the patient was vaccinated with a dose of GARDASIL 9 (dose: 0.5 ml, lot # M004116, expiration date: 12-OCT-2017) intramuscularly. On 20-JUL-2016, the patient experienced seizure. On 07-AUG-2016, the patient reported that he had a seizure. The patient was sent to an unspecified neurologist to be evaluated. No treatment was given and no lab diagnostic studies were performed. The outcome of the event was unknown. The causal relationship between the event and GARDASIL 9 was unknown. Upon internal review, seizure was considered to be medically significant. Additional information is not expected as no consent for follow-up was given.
Age: 5.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a pharmacist concerning a 5 year old patient of unknown gender. Information on pertinent medical history and concurrent condition was not reported. On an unknown date, the 5 year old patient was vaccinated with ZOSTAVAX lot # M010472, expiry date: 01-JUN-2017, subcutaneously (inappropriate schedule of vaccine administered). No adverse effects were reported. No PQC involved. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from office manager regarding a 6 month old female patient. The patient had no medical history, concomitant medications and drug reactions/allergies. On 17-FEB-2016, the patient was vaccinated with a dose of VAQTA, 0.5 ml, intramuscularly, lot # L015460, expiry date: 13-APR-2017, instead of RECOMBIVAX HB due to a clerical error. The patient did not seek medical attention. No treatment was given and no lab studies were performed. The nurse who administered the vaccine was no longer practicing at facility so the reporter was unable to verify it the two products were confused. They did not realize the error had been made until 16-AUG-2016. It was not specified how they caught the error. No product quality complaint (PQC) involved. 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 health care worker referring to multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with an improperly stored doses PROQUAD which had lot # L050910, expiry date: 14-JUN-2017 and lot # M004894, expiry date: 26-JULY-2017 (strength, dose and route not reported). No adverse effects reported. No product quality complaint (PQC) involved. No further information 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: Information has been received from a medical assistant referring to multiple unknown patients. The patients' concurrent condition, medical history and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored (6.6 degrees Fahrenheit for 30 minutes) doses of VARIVAX (dose and route were unknown, lot # and expiration date were M009764, 23-FEB-2018; M14309, 21-MAR-2018; M015731, 30-MAR-2018). No previous temperature excursion was reported. Data logger was involved. No adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring multiple unspecified patients of unknown age and gender. Their medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were administered improperly stored VARIVAX (strength, dose, frequency and route were unknown; lot number M015731 with and expiration date as 30-MAR-2018; M006156 with expiration date as 05-FEB-2018; M009768 with and expiration date as 23-FEB-2018; M017290 with and expiration date as 07-APR-2018 and M008171 with and expiration date as 16-FEB-2018). No Adverse effects were reported. This is one of the two reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 11-AUG-2016, the patient was vaccinated with a dose of M-M-R II (lot # L040961, expiration date 19-OCT-2017) subcutaneously, which was inadvertently reconstituted with a dose of VAQTA (lot# L023232, expiration date 25-FEB-2017) instead of sterile water diluent (manufacture unknown). It was reported that the patient was intended to receive both M-M-R Ii and VAQTA. The reporting medical assistant stated that the error occurred because VAQTA was mistaken for sterile water diluent (manufacture unknown) as the label colors were the same. No adverse effect was reported. 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 health care worker referring to multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with an improperly stored dose of GARDASIL 9 which had lot # L024993, expiry date: 17-OCT-2017 (strength, dose and route not reported). No adverse effects reported. No product quality complaint (PQC) involved. No further information 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 was received from a health care worker referring to multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with an improperly stored doses of VARIVAX which had lot # L043624, expiry date: 03-NOV-2017 and lot # M000761, 06-JAN-2018 (strength, dose and route not reported). No adverse effects reported. No product quality complaint (PQC) involved. No further information reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a doses of PNEUMOVAX 23 (doses, routes, lot numbers and expiration dates were not reported). On an unknown date the patients experienced injection site reactions. The patients sought medical attention via contacting the physician. The outcome of injection site reaction was unknown. Relatedness between the event and the therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Infantile vomiting
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 2 month old male patient. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 15-AUG-2016, the patient was vaccinated with ROTATEQ, 2 ml, orally, lot# M019690, expiry date 02-NOV-2017. On the same date, the patient vomited 3 times. No treatment was given for the adverse event. The outcome of the event was unknown. The patient sought medical attention (no details provided). The relatedness between the event and ROTATEQ was not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: RAB
Symptoms: Balance disorder, Headache, Meningitis aseptic, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of aseptic meningitis in a 63-year-old female patient who received RABAVERT. Concomitant products included RABAVERT. On 31st July 2016, the patient received the 2nd dose of RABAVERT 1 ml. On an unknown date, less than a week after receiving RABAVERT and an unknown time after receiving RABAVERT, the patient experienced aseptic meningitis (serious criteria hospitalization and GSK medically significant), headache (serious criteria hospitalization), unsteadiness (serious criteria hospitalization) and rash (serious criteria hospitalization). On an unknown date, the outcome of the aseptic meningitis was not recovered/not resolved and the outcome of the headache, unsteadiness and rash were unknown. It was unknown if the reporter considered the aseptic meningitis, headache, unsteadiness and rash to be related to RABAVERT. Additional details were reported as follows: The patient was vaccinated (post exposure) on 28th July 2016 for 1st of RABAVERT. The patient was then hospitalized on 1st August 2016 for, headache, unsteady feet, rash on both arms, and was still hospitalized due to aseptic meningitis. No further information was known to the physician.
Age: 85.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rash, Skin warm
Clinical narrative: Injection given 8/12/16 pt returned 8/17 with large hot rash covering exterior area of bicep. Patient has an apt with MD in afternoon will follow up - FLUZONE HD give RA same day.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: Administered 8/16/16. Tuesday night pain and redness started in arm. Wednesday pm fever started: pt reports 100.4. Pt administered TYLENOL immediately and fever subsided. Current temp 97.8.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Amylase, Bacterial test negative, Clostridium test, Computerised tomogram pelvis
Clinical narrative: Fever, nausea, vomiting, diarrhea, abdominal pain began 1 day after booster given.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Full blood count, Lipase, Metabolic function test, Nausea
Clinical narrative: Fever, nausea, vomiting, diarrhea, abdominal pain began 1 day after booster given.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, nausea, vomiting, diarrhea, abdominal pain began 1 day after booster given.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Dyspnoea, Influenza like illness, Pyrexia, Rash, Rash generalised
Clinical narrative: Approx. 36 hrs. after vaccination, developed fever, flu-like illness, rash, vomiting, and shortness of breath. Rash started on right upper arm at vaccine site and spread to body. Was treated with IVF, IV steroids, BENADRYL and albuterol. Was discharged on steroid taper.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Vaccination site rash, Vomiting
Clinical narrative: Approx. 36 hrs. after vaccination, developed fever, flu-like illness, rash, vomiting, and shortness of breath. Rash started on right upper arm at vaccine site and spread to body. Was treated with IVF, IV steroids, BENADRYL and albuterol. Was discharged on steroid taper.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Cough, Drooling, Erythema, Rash macular
Clinical narrative: Wheezing, coughing, rapid distressed breathing, splotchy, red face and arms, drooling.  Anaphylaxis.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Respiratory distress, Respiratory rate increased, Wheezing
Clinical narrative: Wheezing, coughing, rapid distressed breathing, splotchy, red face and arms, drooling.  Anaphylaxis.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: "Flu-ey" feeling, Aching allover, extreme fatigue, unable to perform usual tasks, took bed rest most of the day; feverish in evening, temp 99.8.  Fever subsided later in evening.  Felt better next morning but aching/fatigue returning 10:00am at this writing.
Age: 5.0
Sex: F
Vaccine: DTAP, FLUX, IPV, MMR
Symptoms: Acne, Injection site induration, Injection site nodule, Injection site pain, Skin discolouration
Clinical narrative: Hard painful knot at injection site for what seemed to last forever; acne developed on nose; neck started having a "dirty appearance"; 6 months later developed strong body odor.
Age: 5.0
Sex: F
Vaccine: DTAP, FLUX, IPV, MMR
Symptoms: Skin odour abnormal
Clinical narrative: Hard painful knot at injection site for what seemed to last forever; acne developed on nose; neck started having a "dirty appearance"; 6 months later developed strong body odor.
Age: 5.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes all around neck. 4 larges one.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash
Clinical narrative: Rash on back and bottom.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint injury, Musculoskeletal pain
Clinical narrative: Shoulder injury related to vaccine administration. Shoulder pain.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 19 year old patient (gender not specified). The patient's concurrent conditions, medical history and concomitant medication use was not provided. The pharmacist reported that when this patient was a child he or she was vaccinated with two doses of VARIVAX, (dates of vaccinations, dose administered, lot#s and expiration dates were not provided). On an unspecified date the patient had serologic testing done and was found to have low titers to varicella. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 69 years old female patient; Historical condition included varicella. The patient's concurrent conditions and concomitant therapies were not reported. The patient reported that on an unspecified date, she was vaccinated with ZOSTAVAX "1 time vaccine" for prevent shingles (route of administration was reported as "vaccine", strength, dose, lot number and expiration date were not provided); but in OCT-2012, got the shingle. Three years later, in approximately 2015, the patient experienced another case of shingles. The patient sought unspecified medical attention. At the time of this report, the outcome of the events was unknown. The causality between the aforementioned events and ZOSTAVAX was unknown. No product quality complaint (PQC) was involved. Additional information is not expected, as there was no consent to contact the physician.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report concerning multiple unspecified patients of unknown gender and age was received from a nurse on 06-JUL-2016. No concomitant medications, concurrent conditions or medical history were reported. The nurse called back on 07-JUL-2016 and reported that on an unknown date, multiple unspecified patients received doses of improperly stored (albumin status to be confirmed) PROQUAD lot # M006106, expiration date 01-AUG-2017 (strength, dose, route and frequency not reported) or VARIVAX lot# reported as K024036, expiration date 26-NOV-2016, (strength, dose, route and frequency not reported). There were no adverse effects reported. No further information was provided. Information received on 21-JUL-2016 reported that therapy type for PROQUAD was recombinant human albumin (rHA).  Lot# K024036 is an invalid lot# for varicella virus vaccine live (Oka/Merck). Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hypotension, Pallor, Tinnitus
Clinical narrative: This spontaneous report as received from a 26 year old female patient reporting on herself. The patient's mother was also a reporter. The patient did not have important pertinent medical history or drug reactions nor allergies. On 05-AUG-2016 in the late afternoon, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly. Concomitant therapies included LEXAPRO. On 05-AUG-2016, within maybe a minute, after receiving the vaccine, she proceeded to leave the clinic. As the patient was leaving, her ears began ringing and she started to feel dizzy. She sat in a chair in the waiting room and the dizziness progressed. A nurse practitioner handed her a cup of water and said stated that she looked very pale so advised her to sit for a bit. Also the nurse practitioner took the patient's blood pressure and it read 90/60 unit not provided. She indicated this was low for blood pressure and gave her a lollipop to give her a sugar boost. Lab diagnostic studies were not performed. The patient also stated that after 20 minutes that day, she felt much better and left the clinic on her own. The outcome of the events was reported as recovered/resolved on 05-AUG-2016. Causality assessment was not reported. Additional information is not expected, because contact details were not provided.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Pt was given immunization in right deltoid 08/15/2016. Presented following day 08/16/2016 to walk-in with warm, red, slightly itchy arm. Inj. site was reported to be normal looking, with no evidence of infection, no drainage, discoloration or swelling. Pt was encouraged by nurse to apply ice pack and take BENADRYL if needed, follow up if any shortness of breath, difficulty breathing, and/or worsening of symptoms.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient of an unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PROQUAD (dose, lot# expiration date and route of administration were not reported). On 08-AUG-2016, the patient was vaccinated with the second dose of PROQUAD lot # M015700 with expiration date: 26-SEP-2107 (dose and route of administration were not reported) that was improperly stored. Administered dose of PROQUAD underwent excursions at -12.8 degrees Celsius, for 66 hours and 15 minutes. There was not previous temperature excursion. Data logger was not involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). Concomitant therapy was not reported. The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No adverse effect was reported. This is one of several reports from the same source. 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 medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). No concomitant therapy was reported. The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.