chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TDAP
Symptoms: Death neonatal, Foetal exposure during pregnancy
Clinical narrative: Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092724 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of TDAP (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine was exposure in utero, thus 526 numbers of neonate patients out of which 99 (1 percentage) patients gestational age at delivery was 34 or less weeks and 427 (6 percentage) patients gestational age at delivery was 36 or less weeks. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Adverse reaction
Clinical narrative: Initial unsolicited report received from a consumer on 15 July 2015. A female patient, whose medical history and concomitant medications were not reported, had received a dose of (Dtap) (batch number, route and site of administration were not reported) on unspecified date 11 years ago. On unspecified date after vaccination, the patient had an extreme reaction. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site nodule
Clinical narrative: Initial unsolicited report received from a nurse on 21-Jul-2015. A 40 years old female patient, had received first dose of ADACEL via intramuscular route in the right deltoid (batch number: C4730BA, expiry date and dose details were not provided) on 16-Jul-2015. There was no illness at the time of vaccination and no known pre-existing physician diagnosed allergies, birth defects and medical conditions. On 19-Jul-2015, 3 days post-vaccination, the patient developed a knot feeling in the right deltoid area at the injection site (20 mm diameter) with a reddened area (50 by 70 mm) which persisted till date. Laboratory investigations and corrective treatment were not provided. It was reported that she required ER/doctor visit. At the time of this report, the patient had not recovered from the above mentioned event. Documents held by sender: none. Follow up information received from a nurse on 18-Aug-2015. A patient received 0.5 ml dose of ADACEL (expiration date 24-Apr-2017) on 16-Jul-2015. It was reported that patient did not require any emergency room visit. Patient did not undergo any laboratory tests. On an unspecified date, the patient recovered from the events.
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial unsolicited report received from a nurse 21 July 2015. A female patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of TDAP VACCINE (batch number, route, dose in series not reported) in left deltoid and also received a dose of MCV4 (batch number not reported) in left deltoid on an unspecified date. On an unspecified date after the vaccination the patient experienced redness, swelling and pain at the injection site. The patient was vaccinated at a clinic. Laboratory investigations and corrective treatments were not reported. At the time of this report the event outcome was not reported. Documents held by sender: none.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Anaphylactic reaction, Cough, Fatigue, Hypotension
Clinical narrative: Initial unsolicited report received from a physician on 06 August 2015. A three years old male patient (exact age at onset was three years and nine months), whose medical history and concomitant medications were not reported, had received a dose of IPOL (batch number-K1649, site of administration was not reported) via intramuscular route, a dose of DAPTACEL (batch number-C4694AA and site of administration was not reported) via intramuscular route, a dose of MMR (manufacturer- Merck, batch number, route and site of administration were not reported) and a dose of VARIVAX (manufacturer- Merck, batch number, route and site of administration were not reported) on 09 March 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. On 09 March 2015, 15-30 minutes post vaccination, the patient experienced red rash, hives, coughing, wheezing, fatigue, unusual behavior, hypotension and dusky lips. Patient was diagnosed with anaphylactic reaction and etiology was yet to be determined. Patient required ER/doctor visit. It was reported that patient was treated (treatment was unspecified) and evaluated in the hospital. Laboratory investigations and corrective treatments were not reported. On an unspecified date, the patient recovered from all the events. Documents held by sender: none. Sender's Comments: This case meets level 2 of the Brighton Collaboration case definition for anaphylaxis. Anaphylactic reaction is listed with both IPV (VERO) and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. Also the time to onset and symptoms are compatible with the diagnosis. Information on adverse reactions to previous vaccinations and identification of the culprit antigen would be helpful to further assess this case. Further as four vaccines were administered concomitantly, it is difficult to assess the role of each vaccine in particular. Based on the information available, no conclusion can be drawn.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Lip discolouration, Rash erythematous, Urticaria, Wheezing
Clinical narrative: Initial unsolicited report received from a physician on 06 August 2015. A three years old male patient (exact age at onset was three years and nine months), whose medical history and concomitant medications were not reported, had received a dose of IPOL (batch number-K1649, site of administration was not reported) via intramuscular route, a dose of DAPTACEL (batch number-C4694AA and site of administration was not reported) via intramuscular route, a dose of MMR (manufacturer- Merck, batch number, route and site of administration were not reported) and a dose of VARIVAX (manufacturer- Merck, batch number, route and site of administration were not reported) on 09 March 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. On 09 March 2015, 15-30 minutes post vaccination, the patient experienced red rash, hives, coughing, wheezing, fatigue, unusual behavior, hypotension and dusky lips. Patient was diagnosed with anaphylactic reaction and etiology was yet to be determined. Patient required ER/doctor visit. It was reported that patient was treated (treatment was unspecified) and evaluated in the hospital. Laboratory investigations and corrective treatments were not reported. On an unspecified date, the patient recovered from all the events. Documents held by sender: none. Sender's Comments: This case meets level 2 of the Brighton Collaboration case definition for anaphylaxis. Anaphylactic reaction is listed with both IPV (VERO) and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. Also the time to onset and symptoms are compatible with the diagnosis. Information on adverse reactions to previous vaccinations and identification of the culprit antigen would be helpful to further assess this case. Further as four vaccines were administered concomitantly, it is difficult to assess the role of each vaccine in particular. Based on the information available, no conclusion can be drawn.
Sex: U
Vaccine: TDAP
Symptoms: VIIth nerve paralysis
Clinical narrative: Initial unsolicited report received from the literature on 14 September 2015. This case is linked to 2015SA146032, 2015SA146043, 2015SA146044, 2015SA146045, 2015SA146046, 2015SA146047, 2015SA146048, 2015SA146050,2015SA146051, 2015SA146052, 2015SA146053, 2015SA146054, 2015SA146055, 2015SA146056, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146064, 2015SA146065 and 2015SA146066, 2015SA146067 (Same literature). The following is verbatim from the article: Background: Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods: ESP-VAERS monitors patients' electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the Health System, an integrated healthcare system. We queried the VAERS database to determine Health's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results: In the 8 months following implementation, 91,622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable pre-implementation period. Conclusions: An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. Keywords: Vaccine; immunization; adverse reaction; reporting; adverse event. This case involves patient (age and gender not reported), who was vaccinated with a dose of TDAP (manufacturer: unknown, batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On unspecified date following the vaccination, the patient had experienced Bell's palsy. Laboratory tests and corrective treatments were not reported. The outcome of the event was not reported. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Local reaction, Vaccination complication
Clinical narrative: Initial unsolicited report received from the literature on 14 September 2015. This case is linked to 2015SA146032, 2015SA146043, 2015SA146044, 2015SA146045, 2015SA146046, 2015SA146047, 2015SA146048, 2015SA146049, 2015SA146050, 2015SA146051, 2015SA146053, 2015SA146054, 2015SA146055, 2015SA146056, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146064, 2015SA146065, 2015SA146066 and 2015SA146067 (Same literature). The following is verbatim from the article: Background: Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals.We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods: ESP-VAERS monitors patients' electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the Health System, an integrated healthcare system. We queried the VAERS database to determine Health's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results: In the 8 months following implementation, 91,622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable pre-implementation period. Conclusions: An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. This case involves patient (age and gender not reported), who was vaccinated with a dose of Tdap (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On unspecified date following the vaccination, the patient had experienced local immunization reaction. Laboratory tests and corrective treatments were not reported. The outcome of the event was not reported. Documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Periarthritis
Clinical narrative: Initial unsolicited report received from a physician on 05 October 2015. This case involves a male patient (age not reported) who was vaccinated with a dose of ADACEL (batch number: C4765AA, expiry date: 07 July 2017, dose, dose in series, route and site of administration were not reported) on 29 September 2015. The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. The patient had previously received vaccine (unspecified). Concomitant medications were not reported. On 30 September 2015, one day following the vaccination, the patient had developed frozen shoulder which was better but still stiff. The patient required ER/doctor visit. Laboratory data and corrective treatment was not reported. The patient was not recovered from the event. List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Dyskinesia, Erythema, Injection site mass, Injection site rash, Mass
Clinical narrative: Initial unsolicited report received from a non- healthcare professional (office manager) on 15 October 2015. This case involves a 24-months-old male patient who was vaccinated with a fourth dose of DAPTACEL intramuscularly in left leg (batch no C4887AA, expiry date 16 July 2016) and a dose of FLUZONE intramuscularly in the right leg (Batch number- U5321CB, expiry date: 30 June 2016, dose in series was not reported) both on 13 October 2015. The patient's illness at time of vaccination was unknown, pre-existing physician diagnosed allergies with Amoxicillin birth defects and medical conditions and birth defects was not reported. Concomitant medication was not provided. On 14 October 2015, one day after vaccination, patient had red lump and rash which spread away from the shot down to the foot and into the diaper area. In the night patient had uncontrolled spasm like movements first with arms then legs. It happened at least 4 times in 1 hour. The patient had occasional uncontrolled movements of arms. During these movements he was alert, followed instructions including touching his nose but with difficulty. When legs were spasming he tried to hold them down and had "ouchies" on his arms. No fevers, eating, drinking and playin normal. The patient required ER/doctor visit. The patient's laboratory data was not reported. The patient received BENADRYL as corrective treatment and rash "calmed down". The patient had not recovered from the above mentioned events. Follow-up information received from a non-health care professional on 21 December 2015. No new information reported. List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Muscle spasms, Rash
Clinical narrative: Initial unsolicited report received from a non- healthcare professional (office manager) on 15 October 2015. This case involves a 24-months-old male patient who was vaccinated with a fourth dose of DAPTACEL intramuscularly in left leg (batch no C4887AA, expiry date 16 July 2016) and a dose of FLUZONE intramuscularly in the right leg (Batch number- U5321CB, expiry date: 30 June 2016, dose in series was not reported) both on 13 October 2015. The patient's illness at time of vaccination was unknown, pre-existing physician diagnosed allergies with Amoxicillin birth defects and medical conditions and birth defects was not reported. Concomitant medication was not provided. On 14 October 2015, one day after vaccination, patient had red lump and rash which spread away from the shot down to the foot and into the diaper area. In the night patient had uncontrolled spasm like movements first with arms then legs. It happened at least 4 times in 1 hour. The patient had occasional uncontrolled movements of arms. During these movements he was alert, followed instructions including touching his nose but with difficulty. When legs were spasming he tried to hold them down and had "ouchies" on his arms. No fevers, eating, drinking and playin normal. The patient required ER/doctor visit. The patient's laboratory data was not reported. The patient received BENADRYL as corrective treatment and rash "calmed down". The patient had not recovered from the above mentioned events. Follow-up information received from a non-health care professional on 21 December 2015. No new information reported. List of documents held by sender: none.
Sex: M
Vaccine: FLUX, PNC13, TDAP, FLUX, PNC13, TDAP
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse on 26 October 2015. "That report is from a Partner and contact information in based upon the location of our trading partner". This case involves a male patient (age was not reported) who was vaccinated with dose of TDAP Vaccine (batch number, dose, dose in series, route and site of administration were not reported); with a dose of Flu Vaccine (batch number, dose, dose in series, route and site of administration were not reported) and with PREVNAR 13 (batch number, dose, dose in series, manufacturer: other, route and site of administration were not reported) on an unspecified date. The patient was a heart transplant recipient. Concomitant medications were not reported. On an unknown date following the vaccination, the patient developed a fever of 104 degree Fahrenheit and taken to the emergency room. Laboratory data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Injection site cellulitis, Nausea, Pyrexia, Tachycardia
Clinical narrative: Initial unsolicited report received from a physician on 30 October 2015. This case involves a (age unknown) female patient who was vaccinated with a intramuscular [dose series not reported] dose of DAPTACEL (batch number C4887AA, expiry date was not reported) in left gluteal area on an unspecified date. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications was not reported. On an unspecified date, same day following the vaccination patient experienced cellulitis at injection site on left gluteal area, fever, tachycardia, nausea and dizziness. It was reported that, patient required emergency room (ER)/doctor visit. Laboratory investigation and corrective treatment was not reported. The outcome of event was not recovered. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: Based on additional information received on 28 March 2016, this case became medically confirmed. Initial unsolicited report received from a non- healthcare professional on 11 November 2015. This case involves two patients (age and gender not reported) who was vaccinated with 0.5 ml of INFLUENZA QUADRIVAL A-B VACCINE (QIV) (batch number, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed major swelling. Laboratory data 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 nurse on 28 March 2016. It was updated that the swelling was typical localized. No additional information provided.
Sex: M
Vaccine: FLUX
Symptoms: Blood glucose increased, Musculoskeletal pain
Clinical narrative: Initial unsolicited report received from a consumer on 22 March 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of Influenza vaccine (Flu vaccine) (Batch number, expiry date, dose, dose number, route and site of administration were not reported) on an unspecified date in 2015. The patient's medical history includes liver transplant. Concomitant medication includes HUMALOG and LANTUS. On an unspecified date following the vaccination, the patient had pain in the shoulder for which the patient took cortisone shot which caused a diabetic rash and raised his sugar level. The patient's laboratory data includes increase in sugar level in 300's. Patient received cortisone shot as corrective treatment. The outcome of the event was not reported. List of documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Ataxia, Blood test, Computerised tomogram, Electromyogram, Guillain-Barre syndrome
Clinical narrative: Initial unsolicited report received from other non- healthcare professional 30 March 2016. This case involves 62-year-old female patient who was vaccinated with first dose of ADACEL (batch number- C4697AA, site of administration not reported) in left gluteal on 04 September 2015. The patient had no known allergy and medical history included obesity, typhoid nodule, spinal stenosis, carpal tunnel and hypertension. Illness at time of vaccination was reported as none. The patient's concomitant medications were not reported. On an unspecified date, about a month following the vaccination, the patient had experienced progressive weakness in legs and felt like there was a bad around one. On 20 November 2015, two months following the vaccination, the patient had experienced ataxia and severe numbness in all extremities and diagnosed with Guillain Barre Syndrome. On 25 October 2015, the patient was hospitalized for 5 days. On 20 November 2015, patient was hospitalized till 01 December 2015. Lab data included electromyography CT scan, MRI Spinal Tap and blood work. The patient's corrective treatment was not reported. The outcome of events was reported as not recovered. List of documents held by sender: none.; Sender's Comments: The reported symptoms are suggestive of the diagnosis of GBS. Time to onset is compatible with the role of the vaccine. Some contributing factors could be the patient's advanced age and the patient's underlying medical conditions including Carpal tunnel, spinal stenosis, hypertension, Typhoid nodule etc. Complementary investigation results (electromyogram, CSF cell counts and units for protein levels, tendon reflex examination), as well as etiological infectious work-up for this pathology which is often preceded by an infection, the most frequent being Campylobacter jejuni, are needed to further asses this case. Based on the available information, no conclusion on a role of the vaccine can be drawn.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging spinal
Clinical narrative: Initial unsolicited report received from other non- healthcare professional 30 March 2016. This case involves 62-year-old female patient who was vaccinated with first dose of ADACEL (batch number- C4697AA, site of administration not reported) in left gluteal on 04 September 2015. The patient had no known allergy and medical history included obesity, typhoid nodule, spinal stenosis, carpal tunnel and hypertension. Illness at time of vaccination was reported as none. The patient's concomitant medications were not reported. On an unspecified date, about a month following the vaccination, the patient had experienced progressive weakness in legs and felt like there was a bad around one. On 20 November 2015, two months following the vaccination, the patient had experienced ataxia and severe numbness in all extremities and diagnosed with Guillain Barre Syndrome. On 25 October 2015, the patient was hospitalized for 5 days. On 20 November 2015, patient was hospitalized till 01 December 2015. Lab data included electromyography CT scan, MRI Spinal Tap and blood work. The patient's corrective treatment was not reported. The outcome of events was reported as not recovered. List of documents held by sender: none.; Sender's Comments: The reported symptoms are suggestive of the diagnosis of GBS. Time to onset is compatible with the role of the vaccine. Some contributing factors could be the patient's advanced age and the patient's underlying medical conditions including Carpal tunnel, spinal stenosis, hypertension, Typhoid nodule etc. Complementary investigation results (electromyogram, CSF cell counts and units for protein levels, tendon reflex examination), as well as etiological infectious work-up for this pathology which is often preceded by an infection, the most frequent being Campylobacter jejuni, are needed to further asses this case. Based on the available information, no conclusion on a role of the vaccine can be drawn.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hypersensitivity, Vaccination complication
Clinical narrative: Initial unsolicited report received from a health care professional via other company (Pfizer) on 05 April 2016. Manufacturer Report Number: 2016180314. This case involves a female patient (age not reported) who was vaccinated with a dose of Influenza vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient developed allergy due to flu vaccine. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Contusion, Genital herpes, Rash, Skin discolouration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of genital herpes in a 54-year-old female patient who received ENGERIX B adult (batch number 4XM2T, expiry date 9th May 2018). The patient's past medical history included genital herpes. Concurrent medical conditions included mental disorder nos. Concomitant products included aspirin. On 25th March 2016, the patient received ENGERIX B adult 1 ml. On an unknown date, less than one month after receiving ENGERIX B adult, the patient experienced genital herpes, skin discoloration, bruising of arm and rash. On an unknown date, the outcome of the genital herpes, skin discoloration, bruising of arm and rash were not recovered/not resolved. It was unknown if the reporter considered the genital herpes, skin discoloration, bruising of arm and rash to be related to ENGERIX B adult. Additional details provided were as follows: The nurse reported that one of their patients returned at the time of reporting associating several side effects (reactivation of genital herpes, discoloration of inner thigh, bruise in her upper arm and rash) to the ENGERIX B vaccination that the patient received on 25th March 2016. The patient had a bruise on her upper arm, however the nurse explained that the bruise was in the opposite side where she receive the injection.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Impaired work ability, Influenza like illness, Pyrexia, Skin lesion
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a currently 71 year old male patient. The patient's concurrent conditions included diabetes and hypertension. The patient's concomitant therapies included atorvastatin, metformin, lisinopril (manufacturer unknown), hydrochlorothiazide (manufacturer unknown) and clopidogrel. The patient did not have any drug reactions or allergies. In October 2015, the patient was vaccinated with a dose of an unspecified influenza virus vaccine (unspecified) and an unspecified time after receiving the flu vaccine, the patient "got sick". On 01-FEB-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # L037797, expiration date: 30-DEC-2016, 0.65 ml, subcutaneously). On 15-FEB-2016, the patient called the pharmacy stating he developed "flu-like symptoms, a fever and lesions all over his body" an unspecified time after receiving ZOSTAVAX. On an unspecified date, the patient was seen by an unspecified physician in regards to the reaction and was prescribed unspecified antifungal cream, unspecified antifungal shampoo and an unspecified antifungal tablet as a treatment. The pharmacist stated the patient picked up all the antifungals on 15-FEB-2016. The patient was again seen by an unspecified physician in regards to the reaction and was prescribed triamcinolone and mupirocin. The pharmacist stated that the patient picked up the triamcinolone and mupirocin on 18-FEB-2016. The pharmacist stated the patient was seen at the pharmacy on 14-APR-2016, and said he was admitted to an unspecified hospital due to the reaction on an unspecified date in 2016 and was discharged on an unspecified date in 2016. No laboratory tests were performed. The patient was claiming it caused significant disability because he missed a lot of work. The outcome of flu-like symptoms, fever and lesions all over the patient's body was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash generalised
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a currently 71 year old male patient. The patient's concurrent conditions included diabetes and hypertension. The patient's concomitant therapies included atorvastatin, metformin, lisinopril (manufacturer unknown), hydrochlorothiazide (manufacturer unknown) and clopidogrel. The patient did not have any drug reactions or allergies. In October 2015, the patient was vaccinated with a dose of an unspecified influenza virus vaccine (unspecified) and an unspecified time after receiving the flu vaccine, the patient "got sick". On 01-FEB-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # L037797, expiration date: 30-DEC-2016, 0.65 ml, subcutaneously). On 15-FEB-2016, the patient called the pharmacy stating he developed "flu-like symptoms, a fever and lesions all over his body" an unspecified time after receiving ZOSTAVAX. On an unspecified date, the patient was seen by an unspecified physician in regards to the reaction and was prescribed unspecified antifungal cream, unspecified antifungal shampoo and an unspecified antifungal tablet as a treatment. The pharmacist stated the patient picked up all the antifungals on 15-FEB-2016. The patient was again seen by an unspecified physician in regards to the reaction and was prescribed triamcinolone and mupirocin. The pharmacist stated that the patient picked up the triamcinolone and mupirocin on 18-FEB-2016. The pharmacist stated the patient was seen at the pharmacy on 14-APR-2016, and said he was admitted to an unspecified hospital due to the reaction on an unspecified date in 2016 and was discharged on an unspecified date in 2016. No laboratory tests were performed. The patient was claiming it caused significant disability because he missed a lot of work. The outcome of flu-like symptoms, fever and lesions all over the patient's body was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: VARCEL
Symptoms: Scab, Skin lesion
Clinical narrative: Information has been received from a physician referring to a 8 week old female patient. No concurrent condition, medical history or concomitant therapy was not reported. On an unspecified date near the end of February 2016, the patient's 1 year old brother was vaccinated with the first dose of (Oka/Merck) VARIVAX (lot # L028278, expiration date on 28-JUL-2017, dose and route unknown). No adverse effect with vaccine recipient. Approximately in March 2016 (reported as 16 days later), the patient experienced varicella as possible transmission (in 2016) following (Oka/Merck) VARIVAX vaccination of her brother. On 19-MAR-2016, the patient was seen in urgent care emergency room and treated with acyclovir for 5 days. The physician reported that patient was doing great, lesion all crusted and had no complications. The varicella was determined clinically in patient and isolates were collected and sent to a doctor for genotype determination. The causal relationship between the events of varicella and secondary transmission, and VARIVAX (Oka/Merck) was not reported. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 21 year old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. In January 2016 (exact date not reported), the patient was vaccinated with the first dose of human papillomavirus (HPV) vaccine - GARDASIL, (dose, injection site, route of administration, lot number and expiration date were not provided). On 14-APR-2016, the patient received the second dose of HPV vaccine - GARDASIL 9, lot number L036245, expiration date: 09-FEB-2018, (dose, injection site and route of administration were not provided) (interchange of vaccine products). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Extra dose administered, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a Licensed Practical nurse (LPN) referring to a pregnant female patient of unknown age. No other relevant medical history or concurrent conditions were reported. On 16-OCT-2012, the patient was vaccinated with her first dose of GARDASIL (lot# H010915, expiration date 13-FEB-2015, intramuscular, dose not reported). The second dose (lot# J007354, expiration date 20-FEB-2016; dose not reported) and third dose (lot# J010668, expiration date 29-APR-2016, dose not reported) were administered on 11-NOV-2013 (inappropriate schedule of drug administration) and 26-AUG-2014 (inappropriate schedule of drug administration) respectively. On 06-APR-2016 (also reported as 06-APR-2017), the patient was vaccinated with a "fourth" dose of GARDASIL 9 (lot # L019297, expiration date 18-AUG-2017, intramuscular) (captured in MARRS#1604USA010835). The nurse reported that the patient was pregnant when the GARDASIL 9 was administered on 06-APR-2016 (unspecified gestation) (maternal exposure before pregnancy). The pregnancy outcome was pending. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug hypersensitivity
Clinical narrative: This spontaneous report was received from a female patient of unknown age via Biogen (other company number: 20168100214172) refers to herself. Concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dose, lot# and expiration data were not reported). On an unknown date the patient experienced allergies to sulfamethoxazole, BACTRIM. Action taken with sulfamethoxazole, BACTRIM, outcome of the event and the causality between the event and ZOSTAVAX were not reported. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dyspnoea, Electroencephalogram, Emotional disorder, Fatigue, Insomnia
Clinical narrative: Within the hour of receiving her 2 month shots my child was inconsolable. I had been warned about being over tired and a slight fever. But I was not prepared for days of fevers, and my child being unable to sleep for more then 20 minutes at a time. When her fever finally cleared she had a weird catch in her breathing. Her pediatrician said it was normal. On 12/16/2015 she stopped breathing in her sleep. I struggled to wake her up. We rushed to the ER. Once awake she seemed fine. We followed up with our pediatrician, who ordered an EEG and put her on reflux medication, though she had no signs of reflux. She also referred us to a pulmonologist. We discovered after a sleep study that she had severe sleep apnea, which she hadn't had during her time in the NICU, as she was born 5 weeks early and was in the NICU for 5 days. She had more episodes where she stopped breathing and I struggled to wake her up, and then they faded and she seemed to be ok. We got the 4 month shots on time and the same thing happened, but the breathing episodes in her sleep were much more frequent- several times a week. Enough time passed after the vaccines that by the time we had our second sleep study that we had begun some holistic detoxing and when we got the test done her sleep study results were normal. Her pulmonologist was shocked that her apnea had cleared up like that.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Respiration abnormal, Respiratory arrest, Sleep apnoea syndrome, Sleep study abnormal
Clinical narrative: Within the hour of receiving her 2 month shots my child was inconsolable. I had been warned about being over tired and a slight fever. But I was not prepared for days of fevers, and my child being unable to sleep for more then 20 minutes at a time. When her fever finally cleared she had a weird catch in her breathing. Her pediatrician said it was normal. On 12/16/2015 she stopped breathing in her sleep. I struggled to wake her up. We rushed to the ER. Once awake she seemed fine. We followed up with our pediatrician, who ordered an EEG and put her on reflux medication, though she had no signs of reflux. She also referred us to a pulmonologist. We discovered after a sleep study that she had severe sleep apnea, which she hadn't had during her time in the NICU, as she was born 5 weeks early and was in the NICU for 5 days. She had more episodes where she stopped breathing and I struggled to wake her up, and then they faded and she seemed to be ok. We got the 4 month shots on time and the same thing happened, but the breathing episodes in her sleep were much more frequent- several times a week. Enough time passed after the vaccines that by the time we had our second sleep study that we had begun some holistic detoxing and when we got the test done her sleep study results were normal. Her pulmonologist was shocked that her apnea had cleared up like that.
Age: 1.12
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Skin eruptions, hives, itching and redness of the skin.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reports redness swelling and itching at injection site.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Arthus reaction.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: LT DELTOID AREA WAS WARM TO TOUCH AND RAISED BELOW FLU INJECTION AREA.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Physician assistant regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 15-APR-2016 the patient was vaccinated with expired dose of ZOSTAVAX lot # K018176, expiration date 10-JAN-2016. No adverse event was reported. The outcome of the event was unknown. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Chills
Clinical narrative: Parents report "shivering" spells daily that last approximately 5 seconds each. These spells started the day after receiving last set of vaccines. She is otherwise well. This history is not consistent with seizures.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Blood test normal, Discomfort, Incisional drainage, Lethargy
Clinical narrative: After vaccination had pimple bump. Felt uncomfortable, lethargic. Bump never resolved. Mentioned it to doctor but did not result in any action. Did not have fever, normal blood tests. On 4/15 bump got larger than golf ball. Went to medical center on Saturday. Doctor lanced it, clear fluid came out as well as 15 mm mass came out. The consistency of mass was like collagen -- it was harder rather than softer. Like hardened plastic. It seems like vaccine was administered IM rather than SC so it was never absorbed. Doctor gave doxycycline to prevent infection after bump burst. The liquid was clear not puss-like. After bump was cleaned had best night sleep, comfortable sleep, for 1 year.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Mass
Clinical narrative: After vaccination had pimple bump. Felt uncomfortable, lethargic. Bump never resolved. Mentioned it to doctor but did not result in any action. Did not have fever, normal blood tests. On 4/15 bump got larger than golf ball. Went to medical center on Saturday. Doctor lanced it, clear fluid came out as well as 15 mm mass came out. The consistency of mass was like collagen -- it was harder rather than softer. Like hardened plastic. It seems like vaccine was administered IM rather than SC so it was never absorbed. Doctor gave doxycycline to prevent infection after bump burst. The liquid was clear not puss-like. After bump was cleaned had best night sleep, comfortable sleep, for 1 year.
Age: 1.89
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Abasia, Agitation, Blister, Body temperature increased, Ear tube insertion
Clinical narrative: 4/8/2016: Vaccine: DTaP (SK 9D7CM) and Hib-PRP-OMP (Merck L038501) to right thigh; and preservative free quad influenza (SP U5387AA) and PCV13 (Pfizer L82219) to left thigh. 4/9/2016: ER LWBS bilateral leg pain, redness, swelling, refuses to walk on legs x 24 hours "since vaccinated yesterday". Temp 101.2F. 4/11/2016: called for immunization reaction - ER. 4/12/2016: ENT visit for tubes in ears (per dad mom say visit was 4/4 for 5 episodes ear infections in the last 6 months. During these episodes, he's fussy, pulls at ears, and has fevers as high as 104. Each episode resolves after antibiotic treatment, however, they often recur 6 weeks later. His father's side of the family has extensive history of ear infections requiring tubes (dad's dad, brother, grandfather). The patient also snores at night but the parents have not noticed episodes consistent with apnea. 4/13/2016: ER: agitated with generalized rash, Temp 99.9 F - providers diagnosed as viral exanthem (varicella). 4/14-18/2016: referral to office. Mom reports her son (18 months of age) began to develop mild fever and red rash to first his trunk and head-face about 4/13/2016 in which he was taken to the ER for and on 4/14 his rash now included bilateral arms and legs. The ER providers note documented this rash as generalized with small vesicles on patches of erythematous skin and being "varicelliform". Childs fever had been treated with TYLENOL with resolution. Child was acting age appropriate, happy and in no acute distress. On 4/15/2016 mom sent me picture of his reaction. Rash had not changed but was not worse and he was acting more himself. On 4/18/2016 mom advised rash was almost gone and no other issues had developed. He was acting his normal self, walking, playing, eating, etc.