chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site induration in a 16-year-old female patient who received MENVEO (batch number X15099, expiry date unknown). On 9th June 2016, the patient received MENVEO. On an unknown date, less than a year after receiving MENVEO, the patient experienced injection site induration and injection site redness. On an unknown date, the outcome of the injection site induration and injection site redness were recovered/resolved. It was unknown if the reporter considered the injection site induration and injection site redness to be related to MENVEO. Additional details were provided as follows: In the morning of reporting date, the sales representative called the office nurse and at this visit they discussed that there were a high number of patients with severe local reactions to the MENVEO and BEXSERO vaccines. These patients were returning to their office with very large, reddened, swollen, hardened, warm induration at the injection site and the surrounding area, many times measuring 6 inches or more from the injection site. The physician had prescribed oral antibiotics for most of these patients. The patient concerned in this case had experienced 5 to 7 mm induration and redness at injection site after vaccination with booster dose of MENVEO, which had lasted for 5 days. She was monitored for the events. The reporter had tried several different methods of mixing the vaccine (letting it sit, administering it immediately, etc) but none had provided effective in reducing reaction rates. The reporter requested for suggestions on how they could possibly reduce the potential for a local reactions. Also, they inquired if there had been any problems with certain lot numbers of the vaccine, so that they could compare those numbers to the vaccines which they administered to their patients. This case has been linked to 4 other cases (MENVEO vaccine), reported by the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L037554 and expiration date 25-DEC-2017) that went to 46.6 F for 8 hours. A data logger was used and there were no prior excursions. The vaccines are back in range. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, IPV, PNC13, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Child was inadvertently given 2 IPV in 2 different sites 9-16-16. Provider notified and stated was fine but to mark IPV #1 and IPV #2 and give Hep B #2 next visit. Contacted manufacturer for whom supplies both vaccines and states this had happened many other times and was ok but to monitor child for any adverse effects and call them if this should occur. Spoke with grandmother as she states mother's phone was out of minutes and she had left with child 9/18/16 to stay at a friend's house whom has no phones. She states child had no problems with 1st set of shots and was doing well. She will have her mother call when she returns but didn't known when this would be.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pain, Local reaction, Swelling
Clinical narrative: Flu vaccines was administer at 1300, at around 1400 associated complain of pain on site, redness and swelling. 8cm x 10cm localize reaction. No anaphylaxis. Swelling and redness decrease still pain on site.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Limb discomfort, Mobility decreased, Pain
Clinical narrative: On 9-14-16, pt. reported this reaction to us: Pt. states on 7-27-16, left arm pain began soon after shot administered. Says 'it felt like my arm was broken'. Had difficulty moving and raising her arm. States pain lasted approximately 3 weeks. At worse, pain was 10/10. Denied any other symptoms. Denied discomfort on 9-14-16. Decision was made not to administer vaccine #2 (Men B).
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: On 9-14-16, pt. reported this reaction to us: Pt. states on 7-27-16, left arm pain began soon after shot administered. Says 'it felt like my arm was broken'. Had difficulty moving and raising her arm. States pain lasted approximately 3 weeks. At worse, pain was 10/10. Denied any other symptoms. Denied discomfort on 9-14-16. Decision was made not to administer vaccine #2 (Men B).
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cough, Hand-foot-and-mouth disease, Impetigo, Pyrexia, Rash pruritic
Clinical narrative: She developed a fever of 103.8F 7 days after getting her 1yo vaccines. Then she developed a runny nose/cough. Then she broke out in a vesicular rash on 9/3/16, that was pruritic. She was seen in the ER on 9/4/16 and diagnosed with HFtM vs. post varicella reaction with secondary impetigo and started on antibiotics.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash vesicular, Rhinorrhoea
Clinical narrative: She developed a fever of 103.8F 7 days after getting her 1yo vaccines. Then she developed a runny nose/cough. Then she broke out in a vesicular rash on 9/3/16, that was pruritic. She was seen in the ER on 9/4/16 and diagnosed with HFtM vs. post varicella reaction with secondary impetigo and started on antibiotics.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Eye swelling, Lip swelling, Rash
Clinical narrative: (Mom) child's mother called 09/01/16 C/O child developed rash on both arms, swollen eyes, and swollen lips that started Wednesday.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Headache, Migraine, Phonophobia, Photophobia
Clinical narrative: Patient developed severe headache, new onset. Also photophobia and phonophobia. Seen in office on 11/23/16, symptoms were improving. They lasted 4-5 days. Diagnosed migraine.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Haemoglobin normal, Headache, Myalgia, Pain
Clinical narrative: Was given TRUMENBA and FLU vaccines on 8/15/16. She was observed in office without difficulty. Mother reports about an hour after vaccine she developed a bad headache. Eventually the headache resolved with Ibuprofen but complained of body/muscle aches for 2 days after.
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Pain
Clinical narrative: Day after shot pain in elbow unable to hold drill. Soreness within elbow non superficial soreness to turn steering wheel, soreness in moving arm in certain positions.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Apathy, Chills, Fatigue, Feeling cold, Hyperhidrosis
Clinical narrative: Cold, nausea (terribly nausea), sweating, fever, aching, pain, chills all over body, fatigue (can't move her body), apathy. (the next morning)-> Take TYLENOL 650 mg -Z tablets Q8H. She feels the same way, in bed for 3 day already.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Cold, nausea (terribly nausea), sweating, fever, aching, pain, chills all over body, fatigue (can't move her body), apathy. (the next morning)-> Take TYLENOL 650 mg -Z tablets Q8H. She feels the same way, in bed for 3 day already.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Flu vaccine was administer at 1300, associated notice redness, swelling and pain at around 1800 the same day of administer. Redness and swelling has decrease but still painful. 10cm x 10cm local reaction Lt Deltoid. No anaphylaxis.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: Received vaccine on Thurs 9/8/16 about 1:00pm Started S&S within approx 5 hrs. Went to a local walk in clinic on Friday-MD took quick look and recommended to monitor. Reaction became worse so went to ER at hospital. Diagnosed as "cellulitis". Antibiotics prescribed. (Doxycycline).
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Received vaccine on Thurs 9/8/16 about 1:00pm Started S&S within approx 5 hrs. Went to a local walk in clinic on Friday-MD took quick look and recommended to monitor. Reaction became worse so went to ER at hospital. Diagnosed as "cellulitis". Antibiotics prescribed. (Doxycycline).
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site swelling, Myalgia
Clinical narrative: Injection site very inflamed and swollen. Pt complains of severe muscle soreness.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Nausea
Clinical narrative: Nausea, chills, sweats, diarrhea.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient had soreness and raised, painful, bruised, rash at sight of injection and under it as well.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injury associated with device, No adverse event
Clinical narrative: Patient was accidentally stuck with a needle that was used to inject flu vaccine for her father. Patient has reported NO adverse events.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Type III immune complex mediated reaction
Clinical narrative: Arthus reaction involving (L) deltoid and 2-3 days following flu vaccine. Self-resolved.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient complained to tech on a repeat trip to pharmacy for pain meds that vaccine administration caused prolonged pain.
Age: 44.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Arthralgia, Fatigue, Immunisation reaction, Injection site swelling, Injection site warmth
Clinical narrative: 9/13/16 muscle aches; joint aches, fatigue, malaise, fever. Took acetaminophen 500mg two tabs at 1600, 1900 and on 9/14/16 0600. 9/14/16 muscle and joint aches minimized no fever, fatigue. Injection site warm and swollen. Seen by Dr, no restrictions. Release. Dx: Immunization reaction.
Age: 44.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: 9/13/16 muscle aches; joint aches, fatigue, malaise, fever. Took acetaminophen 500mg two tabs at 1600, 1900 and on 9/14/16 0600. 9/14/16 muscle and joint aches minimized no fever, fatigue. Injection site warm and swollen. Seen by Dr, no restrictions. Release. Dx: Immunization reaction.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Angioedema, Hypoaesthesia, Lip swelling, Rash, Swelling face
Clinical narrative: Vaccine given in am. Early evening arm had "bumps" all over, fingers numb. Later on face started swelling. Lips swelled. No difficulty breathing. Dx-Angioedema.
Age: 46.0
Sex: F
Vaccine: FLUR3
Symptoms: Hypoaesthesia, Lid sulcus deepened, Nausea
Clinical narrative: Pt c/o facial numbness, nausea, "eyes sunken".
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Culture urine negative, Febrile convulsion, Pyrexia
Clinical narrative: On 09-17-16 child was seen in ED for febrile seizure at home. On 9-16-16 had fever of 102F, temp in ED on 9-17-16 was 100.4F.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: No signs or symptoms consistent with any side effect.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Petechiae, Rash erythematous, Rash macular
Clinical narrative: Pt. rec'd 2 mo imm. in office on 8/23/16. Seen 8/25/16 for round petechial purplish/red macular dots to bilat legs. Afebrile; no URI. No decreased appetite. PCP consulted with cardiologist D/T DX - ? concerns for bleeding D/O or future contraindications. (No concerns noted).
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: 24 hours post admin, upper arm noted to be swollen, and tender to touch. By Sunday, 9/18/2016 limited range of motion, itching to upper arm and swelling.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness
Clinical narrative: Patient described severe flu-like symptoms x 2 days that resolved w/OTC IBU use.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Influenza like illness
Clinical narrative: Patient described sever flu-like symptoms x2 days that resolved w/OTC IBU use.
Age: 60.0
Sex: U
Vaccine: FLU4, PPV
Symptoms: Feeling abnormal, Muscle disorder, Urinary incontinence
Clinical narrative: Patient said he lost muscle control later the same day and lost bladder control temporarily. "Felt bad".
Sex: U
Vaccine: FLU4, PPV
Symptoms: Loss of consciousness
Clinical narrative: Patient says she blacked out while driving.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Pt with syncopal episode after/during HPV #1 admin. Occurred after receiving MENACTRA, Hep A and V2V #2. Vitals nl. Came to after 2-3 sec. Monitored x20 min.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 16-SEP-2016, the patient inadvertently received a dose of ZOSTAVAX(dosing details not known) with lot # L021612 that had expired on 10-SEP-2016, No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HEPA, MMR, TDAP, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a 10 year old female patient with no known drug allergy. The patient had no illness at time of vaccination. Concomitant therapies included VARIVAX, hepatitis a virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 10-MAY-2016 at 12:18, the patient was vaccinated with M-M-R II lot # reported as L042818 dose 2, subcutaneously in the right arm. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to 4 year old male patient with dermatitis contact and no known drug allergy. The patient had common cold at time of vaccination. Concomitant therapies included (Oka/Merck) VARIVAX and KINRIX. On 03-JUN-2016 at 10:41, the patient was vaccinated with (wistar ra 27-3) M-M-R II lot # L042267 dose 2, subcutaneously in the left thigh. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received rom the same reporter. Additional information has been requested. Information
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to 1 year old female patient with no known drug allergy. The patient's birth weight was 7 lb. 7 oz. The patient had Vulvitis at time of vaccination. Concomitant therapies included VARIVAX and hepatitis a virus vaccine (unspecified). On 21-APR-2016 at 14:46, the patient was vaccinated with M-M-R II lot # reported as L042818 dose 1, subcutaneously in the left thigh. The vaccine was improperly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients whose on an unknown date, were vaccinated with an improperly stored doses of GARDASIL (lot # L040459, expiry date 06-APR-2017). The vaccine was exposed to 51 degrees F for 7 hours and 30 minutes. No adverse effects were reported. This is one of two reports from the same reporter source (linked to MARRS# 1609USA009605). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no information regarding concomitant medication, medical history or drug reaction/allergies. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L024993 with expiration date 17-OCT-2017, dose and route were not reported). It was reported that the vaccine was improperly stored at 33.6 (unit not provided) for 89.5 hours and then was back in range. There were no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no information regarding concomitant medications, medical history or drug reaction/allergies. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K026666 with expiration date 22-OCT-2016, dose and route were not reported). It was reported that the vaccine was improperly stored at 33.6 (unit no provided) for 89.5 hours and then was back in range. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no information regarding concomitant medication, medical history or drug reaction/allergies. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L051123 with expiration date 13-OCT-2018, lot # M014926 with expiration date 17-FEB-2019; dose and route were not reported). It was reported that the vaccine was improperly stored at 33.6 (unit not provided) for 89.5 hours and then was back in range. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of unspecified patients. No medical history or concurrent conditions were included. Since 06-SEP-2016, the patients had been administered doses of ROTATEQ (lot#, expiration date, dose, route unspecified) which were improperly stored. No adverse effects reported. This is one of the reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of unspecified patients. No medical history or concurrent conditions were included. Since 06-SEP-2016, the patients had been administered doses of PEDVAXHIB (lot # L042257, expiration date 17-AUG-2018, dose and route unspecified) which were improperly stored. No adverse effects reported. This is one of the reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no information regarding concomitant medication, medical history or drug reaction/allergies. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L029618 with expiration date 20-MAY-2017; dose was not reported; oral). It was reported that the vaccine was improperly stored at 33.6 (unit not provided) for 89.5 hours and then was back in range. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 17-FEB-2016, the patient was inadvertently vaccinated with GARDASIL 9 (dose, route of administration, lot number and expiry date were not reported). Concomitant therapy was not reported. At the time of the vaccination, the patient was unaware of her pregnancy, but the patient was about 4 to 5 weeks gestation, last menstrual period (LMP): 13-JAN-2016 and estimated date of delivery (EDD): 19-OCT-2016). Pregnancy was discovered via unspecified method, an unspecified amount of time after receiving GARDASIL 9 (on an unknown date in 2016). No adverse effect was reported. A product quality complaint was not involved. Follow up information has been received from the reporting registered nurse on 08-SEP-2016, and refers to a 22 years old pregnant female patient. The patient had three previous pregnancies and a total of three full term deliveries, there were none pre-term deliveries, spontaneous abortions, elective terminations, neither fetal deaths. The patient's concurrent conditions include back pain and there were no known allergies. The patient's last menstrual period (LPM) was on 17-JAN-2016 (previously reported as 13-JAN-2016) and estimated date of delivery (EDD): approximately on 23-OCT-2016 (previously reported as 19-OCT-2016). On an unknown date in 2016, the patient experienced pregnancy with anemia, therefore ferrous sulfate iron was given on 26-JUL-2016. It was also reported that the patient experienced chlamydia infection, and received azithromycin as treatment on 23-FEB-2016. She also experienced vaginitis on an unknown date in 2016, clotrimazole, fluconazole, metronidazole and miconazol were given as treatments. Moreover, received ibuprofen and naproxen for the back pain. Additionally the following prenatal tests were performed: on 20-APR-2016, first trimester screening ultrasound (FTS) and maternal Serum Alpha-Fetoprotein First trimester Screening (MSAFP), the result for both lab tests was normal, on 07-JUN-2016, ultrasound of 20 weeks anatomy scan, the result was normal. Ferrous sulfate iron was reported as treatment for anaemia of pregnancy. On 05-JUL-2016, the patient was vaccinated with ADACEL. At the reporting time, the outcome of anaemia of pregnancy, vaginitis and chlamydial infection were not reported. The relatedness between the events and GARDASIL 9 was unknown. The pregnancy outcome was pending and the fetal outcome was unknown. Upon internal review chlamydia infection was considered to be medically significant. Additional information is not expected because all follow ups requested to complete the case were received. Reporter, patient, event information and the narrative have been updated.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Alpha 1 foetoprotein normal, Anaemia of pregnancy, Chlamydial infection, Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 17-FEB-2016, the patient was inadvertently vaccinated with GARDASIL 9 (dose, route of administration, lot number and expiry date were not reported). Concomitant therapy was not reported. At the time of the vaccination, the patient was unaware of her pregnancy, but the patient was about 4 to 5 weeks gestation, last menstrual period (LMP): 13-JAN-2016 and estimated date of delivery (EDD): 19-OCT-2016). Pregnancy was discovered via unspecified method, an unspecified amount of time after receiving GARDASIL 9 (on an unknown date in 2016). No adverse effect was reported. A product quality complaint was not involved. Follow up information has been received from the reporting registered nurse on 08-SEP-2016, and refers to a 22 years old pregnant female patient. The patient had three previous pregnancies and a total of three full term deliveries, there were none pre-term deliveries, spontaneous abortions, elective terminations, neither fetal deaths. The patient's concurrent conditions include back pain and there were no known allergies. The patient's last menstrual period (LPM) was on 17-JAN-2016 (previously reported as 13-JAN-2016) and estimated date of delivery (EDD): approximately on 23-OCT-2016 (previously reported as 19-OCT-2016). On an unknown date in 2016, the patient experienced pregnancy with anemia, therefore ferrous sulfate iron was given on 26-JUL-2016. It was also reported that the patient experienced chlamydia infection, and received azithromycin as treatment on 23-FEB-2016. She also experienced vaginitis on an unknown date in 2016, clotrimazole, fluconazole, metronidazole and miconazol were given as treatments. Moreover, received ibuprofen and naproxen for the back pain. Additionally the following prenatal tests were performed: on 20-APR-2016, first trimester screening ultrasound (FTS) and maternal Serum Alpha-Fetoprotein First trimester Screening (MSAFP), the result for both lab tests was normal, on 07-JUN-2016, ultrasound of 20 weeks anatomy scan, the result was normal. Ferrous sulfate iron was reported as treatment for anaemia of pregnancy. On 05-JUL-2016, the patient was vaccinated with ADACEL. At the reporting time, the outcome of anaemia of pregnancy, vaginitis and chlamydial infection were not reported. The relatedness between the events and GARDASIL 9 was unknown. The pregnancy outcome was pending and the fetal outcome was unknown. Upon internal review chlamydia infection was considered to be medically significant. Additional information is not expected because all follow ups requested to complete the case were received. Reporter, patient, event information and the narrative have been updated.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pregnancy test negative, Ultrasound abdomen normal, Vaginal infection
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 17-FEB-2016, the patient was inadvertently vaccinated with GARDASIL 9 (dose, route of administration, lot number and expiry date were not reported). Concomitant therapy was not reported. At the time of the vaccination, the patient was unaware of her pregnancy, but the patient was about 4 to 5 weeks gestation, last menstrual period (LMP): 13-JAN-2016 and estimated date of delivery (EDD): 19-OCT-2016). Pregnancy was discovered via unspecified method, an unspecified amount of time after receiving GARDASIL 9 (on an unknown date in 2016). No adverse effect was reported. A product quality complaint was not involved. Follow up information has been received from the reporting registered nurse on 08-SEP-2016, and refers to a 22 years old pregnant female patient. The patient had three previous pregnancies and a total of three full term deliveries, there were none pre-term deliveries, spontaneous abortions, elective terminations, neither fetal deaths. The patient's concurrent conditions include back pain and there were no known allergies. The patient's last menstrual period (LPM) was on 17-JAN-2016 (previously reported as 13-JAN-2016) and estimated date of delivery (EDD): approximately on 23-OCT-2016 (previously reported as 19-OCT-2016). On an unknown date in 2016, the patient experienced pregnancy with anemia, therefore ferrous sulfate iron was given on 26-JUL-2016. It was also reported that the patient experienced chlamydia infection, and received azithromycin as treatment on 23-FEB-2016. She also experienced vaginitis on an unknown date in 2016, clotrimazole, fluconazole, metronidazole and miconazol were given as treatments. Moreover, received ibuprofen and naproxen for the back pain. Additionally the following prenatal tests were performed: on 20-APR-2016, first trimester screening ultrasound (FTS) and maternal Serum Alpha-Fetoprotein First trimester Screening (MSAFP), the result for both lab tests was normal, on 07-JUN-2016, ultrasound of 20 weeks anatomy scan, the result was normal. Ferrous sulfate iron was reported as treatment for anaemia of pregnancy. On 05-JUL-2016, the patient was vaccinated with ADACEL. At the reporting time, the outcome of anaemia of pregnancy, vaginitis and chlamydial infection were not reported. The relatedness between the events and GARDASIL 9 was unknown. The pregnancy outcome was pending and the fetal outcome was unknown. Upon internal review chlamydia infection was considered to be medically significant. Additional information is not expected because all follow ups requested to complete the case were received. Reporter, patient, event information and the narrative have been updated.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Hypersensitivity, Injection site induration, Injection site mass, Injection site nodule, Injection site pain
Clinical narrative: Excessive swelling at the site of injection (about the size of a golf ball), extreme pain at site of injection (barely able to raise arm), malaise.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Excessive swelling at the site of injection (about the size of a golf ball), extreme pain at site of injection (barely able to raise arm), malaise.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site pain, Injection site swelling, Malaise
Clinical narrative: Excessive swelling at the site of injection (about the size of a golf ball), extreme pain at site of injection (barely able to raise arm), malaise.
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Staphylococcal infection
Clinical narrative: Initial unsolicited report received from a pharmacist via other company (Merck) (Reference number: 00177784) on 12 September 2016. This case involves a 70-years-old male patient who was vaccinated with a dose of FLUZONE HD (lot number-UI636AB expiratory date- 27 March 2017, site and route were not reported) and 0.5 ml dose of PNEUMOVAX 23 injection by subcutaneous route (lot number -L022262, expiratory date: 05 November 2016, frequency: once, dose in series and site was not reported) on 21 August 2016. The patient's pertinent medical history, drug reactions/allergies was reported as none. It was reported that patient was vaccinated with PREVENAR one year ago. Concomitant medications were reported as nothing new in patient's current medication therapy and were not reported. On an unspecified date, following the vaccination, the patient developed bacterial infection and experienced red swollen arm down to his wrist. It was reported that patient was seen by the nurse practitioner and the nurse practitioner thought that it might be a Staph Cellulitis infection, but was some kind of bacterial infection. Laboratory data was reported as unknown. The patient received corrective treatment with unspecified antibiotic shots. The patient was not recovered from events. List of documents held by sender: none.
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Bacterial infection, Cellulitis staphylococcal, Erythema, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a pharmacist via other company (Merck) (Reference number: 00177784) on 12 September 2016. This case involves a 70-years-old male patient who was vaccinated with a dose of FLUZONE HD (lot number-UI636AB expiratory date- 27 March 2017, site and route were not reported) and 0.5 ml dose of PNEUMOVAX 23 injection by subcutaneous route (lot number -L022262, expiratory date: 05 November 2016, frequency: once, dose in series and site was not reported) on 21 August 2016. The patient's pertinent medical history, drug reactions/allergies was reported as none. It was reported that patient was vaccinated with PREVENAR one year ago. Concomitant medications were reported as nothing new in patient's current medication therapy and were not reported. On an unspecified date, following the vaccination, the patient developed bacterial infection and experienced red swollen arm down to his wrist. It was reported that patient was seen by the nurse practitioner and the nurse practitioner thought that it might be a Staph Cellulitis infection, but was some kind of bacterial infection. Laboratory data was reported as unknown. The patient received corrective treatment with unspecified antibiotic shots. The patient was not recovered from events. List of documents held by sender: none.
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Bacterial infection, Erythema, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a pharmacist via other company (Merck) (Reference number: 00177784) on 12 September 2016. This case involves a 70-years-old male patient who was vaccinated with a dose of FLUZONE HD (lot number-UI636AB expiratory date- 27 March 2017, site and route were not reported) and 0.5 ml dose of PNEUMOVAX 23 injection by subcutaneous route (lot number -L022262, expiratory date: 05 November 2016, frequency: once, dose in series and site was not reported) on 21 August 2016. The patient's pertinent medical history, drug reactions/allergies was reported as none. It was reported that patient was vaccinated with PREVENAR one year ago. Concomitant medications were reported as nothing new in patient's current medication therapy and were not reported. On an unspecified date, following the vaccination, the patient developed bacterial infection and experienced red swollen arm down to his wrist. It was reported that patient was seen by the nurse practitioner and the nurse practitioner thought that it might be a Staph Cellulitis infection, but was some kind of bacterial infection. Laboratory data was reported as unknown. The patient received corrective treatment with unspecified antibiotic shots. The patient was not recovered from events. List of documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Dizziness, Hypertension, Nervousness
Clinical narrative: This spontaneous report was received from a consumer via company (30166392800-0001) on 01-SEP-2016. The consumer was referring to her/himself, a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date the patient was vaccinated with the third dose of GARDASIL (concentration, dose, route of administration, lot #, and expiration date were not provided). There were no concomitant therapies reported. On an unknown date after receiving third dose of GARDASIL, the patient experienced light headed, dizzy and suffered elevated blood pressure. The patient sought treatment at the emergency room. At the time of the report the outcome of dizziness and blood pressure increased was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Anaphylactic shock, Anxiety, Dizziness, Nausea, Tremor
Clinical narrative: This spontaneous report was received from a consumer via company (30166392800-0001) on 01-SEP-2016. The consumer was referring to her/himself, a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date the patient was vaccinated with the third dose of GARDASIL (concentration, dose, route of administration, lot #, and expiration date were not provided). There were no concomitant therapies reported. On an unknown date after receiving third dose of GARDASIL, the patient experienced light headed, dizzy and suffered elevated blood pressure. The patient sought treatment at the emergency room. At the time of the report the outcome of dizziness and blood pressure increased was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: This spontaneous report was received from a consumer via company (30166392800-0001) on 01-SEP-2016. The consumer was referring to her/himself, a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date the patient was vaccinated with the third dose of GARDASIL (concentration, dose, route of administration, lot #, and expiration date were not provided). There were no concomitant therapies reported. On an unknown date after receiving third dose of GARDASIL, the patient experienced light headed, dizzy and suffered elevated blood pressure. The patient sought treatment at the emergency room. At the time of the report the outcome of dizziness and blood pressure increased was unknown. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Erythema, Hypoaesthesia, Neuralgia, Paraesthesia
Clinical narrative: This spontaneous report was received from a 74 years old male patient regarding himself. Pertinent medical history included diabetes. Patient had no drug reactions/allergies. On 26-AUG-2016, the patient received ZOSTAVAX (dosing details not reported). Concomitant medications were not reported. On 31-AUG-2016 (reported as 5 days after vaccination), the patient got shingles down the lower part of his back and down his right leg. The patient stated that he also experienced burning at lower part of leg and numbness. He was having trouble sleeping and he could barely walk because he was in a lot of pain. The patient had not provided any additional information regarding the adverse events. The patient sought medical attention by contacting the physician. Patient received treatment for the events. The patient's physician had prescribed him pain killers to ease the pain (hydrocodone and prednisone) and antiviral medication (VALACYCLOVIR) for break out. Outcome of the events was reported as not recovered. Causality of the events was not reported. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Contusion, Hypoaesthesia, Malaise, Petechiae, Pyrexia
Clinical narrative: This spontaneous report was received from a 74 years old male patient regarding himself. Pertinent medical history included diabetes. Patient had no drug reactions/allergies. On 26-AUG-2016, the patient received ZOSTAVAX (dosing details not reported). Concomitant medications were not reported. On 31-AUG-2016 (reported as 5 days after vaccination), the patient got shingles down the lower part of his back and down his right leg. The patient stated that he also experienced burning at lower part of leg and numbness. He was having trouble sleeping and he could barely walk because he was in a lot of pain. The patient had not provided any additional information regarding the adverse events. The patient sought medical attention by contacting the physician. Patient received treatment for the events. The patient's physician had prescribed him pain killers to ease the pain (hydrocodone and prednisone) and antiviral medication (VALACYCLOVIR) for break out. Outcome of the events was reported as not recovered. Causality of the events was not reported. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Scab, Sensory loss, Varicella
Clinical narrative: This spontaneous report was received from a 74 years old male patient regarding himself. Pertinent medical history included diabetes. Patient had no drug reactions/allergies. On 26-AUG-2016, the patient received ZOSTAVAX (dosing details not reported). Concomitant medications were not reported. On 31-AUG-2016 (reported as 5 days after vaccination), the patient got shingles down the lower part of his back and down his right leg. The patient stated that he also experienced burning at lower part of leg and numbness. He was having trouble sleeping and he could barely walk because he was in a lot of pain. The patient had not provided any additional information regarding the adverse events. The patient sought medical attention by contacting the physician. Patient received treatment for the events. The patient's physician had prescribed him pain killers to ease the pain (hydrocodone and prednisone) and antiviral medication (VALACYCLOVIR) for break out. Outcome of the events was reported as not recovered. Causality of the events was not reported. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Gait disturbance, Herpes zoster, Hypoaesthesia, Insomnia
Clinical narrative: This spontaneous report was received from a 74 years old male patient regarding himself. Pertinent medical history included diabetes. Patient had no drug reactions/allergies. On 26-AUG-2016, the patient received ZOSTAVAX (dosing details not reported). Concomitant medications were not reported. On 31-AUG-2016 (reported as 5 days after vaccination), the patient got shingles down the lower part of his back and down his right leg. The patient stated that he also experienced burning at lower part of leg and numbness. He was having trouble sleeping and he could barely walk because he was in a lot of pain. The patient had not provided any additional information regarding the adverse events. The patient sought medical attention by contacting the physician. Patient received treatment for the events. The patient's physician had prescribed him pain killers to ease the pain (hydrocodone and prednisone) and antiviral medication (VALACYCLOVIR) for break out. Outcome of the events was reported as not recovered. Causality of the events was not reported. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a 74 years old male patient regarding himself. Pertinent medical history included diabetes. Patient had no drug reactions/allergies. On 26-AUG-2016, the patient received ZOSTAVAX (dosing details not reported). Concomitant medications were not reported. On 31-AUG-2016 (reported as 5 days after vaccination), the patient got shingles down the lower part of his back and down his right leg. The patient stated that he also experienced burning at lower part of leg and numbness. He was having trouble sleeping and he could barely walk because he was in a lot of pain. The patient had not provided any additional information regarding the adverse events. The patient sought medical attention by contacting the physician. Patient received treatment for the events. The patient's physician had prescribed him pain killers to ease the pain (hydrocodone and prednisone) and antiviral medication (VALACYCLOVIR) for break out. Outcome of the events was reported as not recovered. Causality of the events was not reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Diplopia
Clinical narrative: Pt has an isolated right 6th nerve palsy.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: VIth nerve paralysis
Clinical narrative: Pt has an isolated right 6th nerve palsy.
Age: 37.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Nausea
Clinical narrative: Cough, Dyspnea, Chest Pressure, Nausea, Emesis, Pruritis.
Age: 37.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Chest discomfort, Cough, Dyspnoea, Nausea, Pruritus
Clinical narrative: Cough, Dyspnea, Chest Pressure, Nausea, Emesis, Pruritis.
Age: 37.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Vomiting
Clinical narrative: Cough, Dyspnea, Chest Pressure, Nausea, Emesis, Pruritis.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Asterixis, Autism, Coordination abnormal, Culture, Developmental delay
Clinical narrative: Regression in speech and motor skills, Developmental delays, autistic disorder, coordination disturbance, drop attacks, hand flapping, repetitive behavior.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Drop attacks, Electroencephalogram, Fine motor skill dysfunction, Speech disorder, Stereotypy
Clinical narrative: Regression in speech and motor skills, Developmental delays, autistic disorder, coordination disturbance, drop attacks, hand flapping, repetitive behavior.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Papule, Rash
Clinical narrative: Rash (Papules, #8) left forearm and upper back.
Sex: F
Vaccine: DTAP
Symptoms: Migraine
Clinical narrative: Initial unsolicited report received from a physician on 12 September 2016. This case involves a female patients (age not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DtaP vaccine) (batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were reported as unknown. On an unspecified date (reported as 15 years ago), following the vaccination, patient experienced migraines. Lab data and corrective treatment were not reported. The outcome of event reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Pain, Rash, Swelling
Clinical narrative: Initial unsolicited report received from nurse on 12-SEP-2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of ADACEL (batch number, expiry date, route and site of administration was not reported) on an unspecified day. Medical history and concomitant medications were not reported. On an unspecified day, after vaccination, the patient experienced Swelling, Pain and Rash. Laboratory investigations and corrective treatments were not reported. Outcome of the events was not reported. Documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from a pharmacist via other company (Merck) (case number: 00181567) on 14-Sep-2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of TETANUS TOXOID (Tetanus Toxoid Adsorbed) (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient had an unspecified allergic reaction. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.