chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Case number PHEH2015US019971, is an initial spontaneous report from a consumer (patient) received on 30 Sep 2015. This report refers to 68 years old female patient. Medical history was not reported. Concomitant medications included B12 injection and other unspecified medications. The patient was bitten by a bat on the left foot. The patient was started with post exposure prophylaxis of RABAVERT (batch number: 556011A, expiry date: Feb 2018) into left arm on 25 Sep 2015. The vaccination did not hurt and it was not thick. On the same day the patient also received HRIG (batch number: unknown, other manufacturer) into left deltoid. As per the patient the HRIG was very thick and syrupy and it "liked to kill" her because it was very painful. The patient reported that it took about 15 seconds for the nurse to administer the full dose and she felt it all the way down her arm to her thumb nails and through her whole body. The patient stated that the nurse even at one point mentioned that she "thinks she did it backwards". The patient stated that the pain continued for some time and throughout the day. The arm pain was so bad that she thought that she was having a heart attack. On 26 Sep 2015 the patient began having flu-like symptoms described as aches and headache which progressively got better but still occurs. The patient stated that currently she does not feel great but is "functional". No hospitalization or ER/doctor visits were necessary. The patient went back for her next dose of RABAVERT on 28 Sep 2015 and that was when she really realized that her original dosing was incorrect. Outcome of vaccination site pain was recovered on 25 Sep 2015. Outcome of aches and headache was improving. Causality of the events of vaccination site pain, aches and headache was reported as almost certain. The outcome and causality of flu like symptoms was not reported. Seriousness criteria were not reported. Seriousness assessment of vaccination site pain was upgraded based on information in the source document.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 12-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # I010145, expiration date 24-MAR-2017 or lot # I028277, expiration date 28-JUL-2017, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates the patients were vaccinated with improperly stored ZOSTAVAX (lot # L016283, expiration date 07-AUG-2016; dose and route not reported). No adverse effects were reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced redness, swelling, and pain at the injection site in the left arm.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 09-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-JAN-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX lot # K016318, expiration date: 24-DEC-2015. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patient was vaccinated with doses of M-M-R II (route of administration, dose, lot number and expiration date were not reported), every year for the last 4 or 5 years. The patient mentioned that she was a travelling nurse and annual vaccination was a requirement for her job. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On unspecified dates, the patient were vaccinated with improperly stored doses of MMR II injection (lot # K021950 with expiration date 10-NOV-2016, albumin status rHA and lot# L009545 with expiration date 19-MAR-2017, albumin status rHA; dose and route were not provided. No adverse effect was reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unspecified dates, the patients received improperly stored doses of ZOSTAVAX lot # L033311 with expiration date 01-DEC-2016 (dose and route of administration were not reported). No adverse effect reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Full blood count, Pneumonia, X-ray
Clinical narrative: DIAGNOSED WITH PNEUMONIA A FEW WEEKS AFTER THE PREVNAR 13 VACCINE.
Age: 67.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Balance disorder, Chest X-ray abnormal, Chest discomfort, Computerised tomogram head
Clinical narrative: DIAGNOSED WITH PNEUMONIA A FEW WEEKS AFTER THE PREVNAR 13 VACCINE.
Age: 67.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Cough, Dizziness, Drug ineffective, Dyspnoea, Hyperhidrosis
Clinical narrative: DIAGNOSED WITH PNEUMONIA A FEW WEEKS AFTER THE PREVNAR 13 VACCINE.
Age: 67.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Laboratory test, Oropharyngeal pain, Pneumonia, Product quality issue, Pyrexia
Clinical narrative: DIAGNOSED WITH PNEUMONIA A FEW WEEKS AFTER THE PREVNAR 13 VACCINE.
Age: 67.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Weight decreased
Clinical narrative: DIAGNOSED WITH PNEUMONIA A FEW WEEKS AFTER THE PREVNAR 13 VACCINE.
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis, seen in urgent care and then by primary care. Treated with antibiotic.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse referring to a patient of unknown age and gender, whose concurrent conditions and medical history were not reported. On 29-NOV-2015 the patient was vaccinated with his/her first dose of MMR II (route, anatomical site of vaccination, lot number and expiration date were not provided) indicated, later on 19-DEC-2015, the patient received his/her second dose of MMR II (route, anatomical site of vaccination, lot number and expiration date were not provided). It was reported that "the doses were given too close together; they were not 28 days apart". No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV1
Symptoms: Immediate post-injection reaction, Underdose, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a 4-month-old patient who received ROTARIX. On an unknown date, the patient received ROTARIX. On an unknown date, immediately after receiving ROTARIX, the patient experienced vomiting and underdose. On an unknown date, the outcome of the vomiting and underdose were unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional details were provided as follows: The healthcare professional reported that the patient spit out majority of the ROTARIX vaccine during administration. This led to an underdose. The healthcare professional reported not having access to further product details. No further information was reported regarding the event.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Lip swelling
Clinical narrative: SWOLLEN LIPS, REDNESS AND SWELLING AT INJECTION SITE.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, C-reactive protein increased, Cellulitis, Erythema, Gait disturbance
Clinical narrative: On 1/4/16 at 12:00 PM, patient started complaining of pain at the injection site.  By 4:30 pm parents reported swelling at the injection site and per health department recommendation began applying ice and Tylenol given for discomfort.  On 1/5/16 patient was still complaining of pain when she awoke and by 3:30 pm parents reported she was having difficulty walking.  On 1/6/16 parents reported that patient was unable to bear weight on her left leg and that her leg was very swollen and red.  Patient was seen later that day at the Doctor's office and they noted she had a temp of 100.0 and noticed some red blotches on her left thigh.  Laboratory testing was done and patient was admitted to hospital with cellulitis.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling, Rash macular, Weight bearing difficulty
Clinical narrative: On 1/4/16 at 12:00 PM, patient started complaining of pain at the injection site.  By 4:30 pm parents reported swelling at the injection site and per health department recommendation began applying ice and Tylenol given for discomfort.  On 1/5/16 patient was still complaining of pain when she awoke and by 3:30 pm parents reported she was having difficulty walking.  On 1/6/16 parents reported that patient was unable to bear weight on her left leg and that her leg was very swollen and red.  Patient was seen later that day at the Doctor's office and they noted she had a temp of 100.0 and noticed some red blotches on her left thigh.  Laboratory testing was done and patient was admitted to hospital with cellulitis.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased, X-ray
Clinical narrative: On 1/4/16 at 12:00 PM, patient started complaining of pain at the injection site.  By 4:30 pm parents reported swelling at the injection site and per health department recommendation began applying ice and Tylenol given for discomfort.  On 1/5/16 patient was still complaining of pain when she awoke and by 3:30 pm parents reported she was having difficulty walking.  On 1/6/16 parents reported that patient was unable to bear weight on her left leg and that her leg was very swollen and red.  Patient was seen later that day at the Doctor's office and they noted she had a temp of 100.0 and noticed some red blotches on her left thigh.  Laboratory testing was done and patient was admitted to hospital with cellulitis.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site mass, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain, swelling, slight discoloration and marble size lump at injection site. Swelling and lump dissipated within 1-2 weeks. Pain at injection site still persists and painful when moving the arm.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site urticaria, Lip disorder
Clinical narrative: Reaction on left side of lip and tongue-swollen.  Rash (hives/itching) at injection site on left arm.  Sore for 7 days.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Swollen tongue
Clinical narrative: Reaction on left side of lip and tongue-swollen.  Rash (hives/itching) at injection site on left arm.  Sore for 7 days.
Age: 84.0
Sex: F
Vaccine: FLUX
Symptoms: Lethargy
Clinical narrative: Lethargic taken to ER.
Age: 12.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Dysgeusia, Headache, Pharyngeal paraesthesia, Throat tightness
Clinical narrative: Throat tingling and tight, H/A, Funny taste in mouth. Gave water to drink. Benadryl 25mg liquid po and Tylenol ES 2 po. V/S stable and observation.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Administration site pain, Immediate post-injection reaction, Injected limb mobility decreased
Clinical narrative: Patient state pain and soreness was experienced on the site of administration of vaccine immediately after flu shot was given on 11-30-15. Patient did not return for treatment until 12-31-15. Until now, pt. cannot move the (L) arm because of pain. Pt referred to physical therapy.
Age: 48.0
Sex: F
Vaccine: FLU3, TYP
Symptoms: Bladder pain, Malaise, Urinary retention
Clinical narrative: Patient calling stating that she was not feeling well after lunch and thought it was possibly due to having been vaccinated so she laid down to take a nap.  When she awoke, she states that she felt like she had to urinate "really bad" so she went into the bathroom but she was not able to void.  She states that she then had extreme pain over the bladder area.  She states she was eventually able to void and now the pain over her bladder area is more mild but she is wondering if this might be a reaction to one of the vaccines she received today.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient experienced 102 F fever on 1/09 which improved with Tylenol. Fever remained off/on for 48 hours. Following the resolution of the fever, the injection site became red, swollen and warm to the touch. Approximate size of a playing card.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Abasia, Gout
Clinical narrative: Patient reports that he had a massive gout attack. He said it happened in both legs, and 1 arm. Patient was unable to walk for 2 months. Patient believes the vaccine caused the gout attack.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Cyanosis, Eye movement disorder, Hyperhidrosis
Clinical narrative: Was seen earlier that day for ADHD F/U. Mom went to restaurant and when she looked back at child, she noticed he dropped food, his eyes rolled back, his lips turned blue and he broke out into a sweat. He seemed to be that way for 3-5 minutes. Dr. seen him at night clinic and sent child to neurology.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Severe pain from her neck to her arm (to wrist). No redness  (some swelling in upper arm and shoulder).
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Headache, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Severe pain from her neck to her arm (to wrist). No redness  (some swelling in upper arm and shoulder).
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Rash pruritic
Clinical narrative: Day after patient received vaccine she broke out in an itchy, lower extremity rash that went up to her knees. Patient had no other allergic reactions, detergents, outside factors that she believes could have contributed. She did not seek medical attention. Pt did apply Calamine lotion to the rash. Spoke with her today (1/12/16) - rash is still present but clearing up and not as itchy. Patient reported event on 1-11-16 via phone.
Age: 1.04
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Acne, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Pimple in right thigh area a week ago. Last night more red. Tender today. Due to location likely MMR or Varivax location - in SQ location. Given 10 days of Keflex to treat for cellulitis beginning 1/12/2016.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Varicella virus test positive
Clinical narrative: Bilateral skin rash dx as herpes zoster. Hx of varicella at age 10 years. No underlying medical conditions reported except skin cancer removed previously.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Peripheral swelling, Skin warm
Clinical narrative: RT ARM SWOLLEN, WARM TO TOUCH, HEADACHE.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: SORE UPPER RT ARM, WARM TO TOUCH, SLIGHTLY SWOLLEN, NO FEVER, NO TYLENOL OR MOTRIN GIVEN BY MOTHER.
Age: 57.0
Sex: F
Vaccine: TYP
Symptoms: Syringe issue
Clinical narrative: The Pre-filled syringe typhoid (Typhim Vi) have been bursting out of the top expelling medications during administration. Thus, causing the medication to not enter the patient's body but instead all over my gloves or furniture.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 22.0
Sex: M
Vaccine: MMR
Symptoms: Epistaxis, Full blood count, Lymphadenopathy, Metabolic function test, Mononucleosis heterophile test
Clinical narrative: Body aches, night sweats, enlarged lymph nodes, bloody nose.
Age: 22.0
Sex: M
Vaccine: MMR
Symptoms: Night sweats, Pain
Clinical narrative: Body aches, night sweats, enlarged lymph nodes, bloody nose.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Fatigue, dizziness, headache, chills, queasy.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: Patient became light-headed and nauseous. She tried to sit down and then had to take a seat and put her feet up in order to not throw-up. The symptoms lasted about 15 minutes in the pharmacy. She said she was feeling a little better about 10 minutes after vaccination. The patient left after about 20 minutes and I am not sure when she fully recovered.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Exposure during pregnancy, Fatigue, Full blood count normal, Mobility decreased
Clinical narrative: Symptoms started with extreme fatigue, followed by nausea and fever. I slept for several hours and woke with a sharp pain in my right side. I still felt extremely exhausted, and was so weak and nauseated that I couldn't get out of bed. I finally reported to OB triage, and after a normal CBC was released. I slept the rest of the day, but it was a full week before my fatigue subsided.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Symptoms started with extreme fatigue, followed by nausea and fever. I slept for several hours and woke with a sharp pain in my right side. I still felt extremely exhausted, and was so weak and nauseated that I couldn't get out of bed. I finally reported to OB triage, and after a normal CBC was released. I slept the rest of the day, but it was a full week before my fatigue subsided.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Forearms red areas on both forearms. Welts appeared within a few hours. Areas are really warm, states "burning". Deny any contact/exposure to anything new.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 81 year old female patient. Medical history and concurrent conditions were reported as none. On 11-DEC-2015, the patient was vaccinated with ZOSTAVAX (lot # L031272, exp.:19-Nov-2016) (dose, frequency and route were not informed). Concomitant medications were reported as none. On an unspecified date, the patient experienced rash at the injection site, itching and redness. The patient was evaluated by her physician and prescribed NYSTATIN to apply topically to the area of reaction. No lab tests were performed. At the time of this report, the outcome of injection site rash, pruritus and erythema was reported on 09-JAN-16 as recovering. Additional information has been requested. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer (manufacturer control#2015464939) on 30-DEC-2015, referring to a 49 year old male patient with hypertension and coronary artery disease. Another concurrent conditions and medical history were not provided. On 25-OCT-2007, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, intramuscular in the left arm (left deltoid), lot number 0697U, expiration date 15-AUG-2009. Concomitant therapies were not reported. The pharmacist mentioned that the patient had swelling of left arm (peripheral swelling) within 24 hour of receiving the injection, that night it was noticed, on 25-OCT-2007. Further, the pharmacist explained that the next he noticed worsening of swelling and redness. So all these started at the night time, the pain, tenderness, redness and swelling. After worsening over night, the next day he was taken to the urgent care the following day (not hospitalized but discharged with prednisone (manufacturer unknown)). None laboratory work was performed. At the time of the report, the outcome of peripheral swelling, erythema, tenderness and pain in extremity was unknown. The reporter did not provide a causality verdict, however he mentioned that the provider considered that the adverse events were related to PNEUMOVAX 23. Batch # 0697U, Lot number 658071/0697U, has been verified to be a valid batch and lot number for PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to an infant patient of unknown age. No medical history or concurrent conditions were reported. On 06-JAN-2016, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5mcg/0.5ml, with lot # reported as L025738 and expiry date of 14-AUG-2017, administered intramuscularly (dosage and dosage number were not reported). On the same day, the patient received a dose of PEDIARIX (dose number, dosage, route, lot # and expiration date not reported) as well. However, no adverse effects were reported. It was not reported whether the patient was vaccinated with any other Hepatitis B vaccine prior to 06-JAN-2016. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy doctor student refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of VARIVAX (Merck) (lot # L027287 exp date 02-JUL-2017) (doses and route not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy doctor student refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of MMR II (lot # K008814 exp date 19-JUN-2016) (doses and route not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant referring to unspecified number of patient of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K014191, expiration date 10-MAY-2017, dose and route were unknown). The previous temperature excursion for GARDASIL was 32.4 F for 4 hours and 30.6 F for 20  minutes. The temperature was 18 F and time frame was 30 minutes. It was not because of "data logger". No adverse effects were reported. No PQC was involved. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a 27 year old female patient referring to herself. The patient was vaccinated with her first dose, second dose and third dose of GARDASIL (dose, lot # and router were unknown) on 06-JAN-2010, 29-JUL-2011 and in 2012, respectively. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MEN, VARCEL, MNQ
Symptoms: Exposure during pregnancy, Pregnancy test positive, Tuberculin test
Clinical narrative: Case number PHHY2015US108569, is an initial spontaneous report received from a nurse via vaccine adverse event reporting system(VAERS reference number: 556596) on n25 Aug 2015. This report refers to an 18-year-old female pregnant patient. Historical conditions were not reported. No concomitant medication was reported. The patient received meningococcal A, C, W-135, Y vaccine (unknown manufacturer, batch number: not reported) along with VARIVAX (batch number: H007450) on 13 Sep 2012. On 02 Dec 2012, the patient was found to be pregnant. The patient became pregnant with LMP (last menstrual period) of 01 Aug 2012 and EDD (estimated delivery date) on 08 May 2013. Initial exposure to VARIVAX was at 6 week. The pregnancy outcome was not reported. In 2012 (exact date unspecified) pregnancy test was done and the patient was pregnant. On 13 Sep 2012, PPD was performed, results not provided. The patient sought unspecified medical attention. No further information was available. This case was identified with a wrong pregnancy outcome during checks: As no more information was obtained, this prospective pregnancy was considered as lost to follow up.
Age: 18.0
Sex: F
Vaccine: MEN, VARCEL, MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHHY2015US108569, is an initial spontaneous report received from a nurse via vaccine adverse event reporting system(VAERS reference number: 556596) on n25 Aug 2015. This report refers to an 18-year-old female pregnant patient. Historical conditions were not reported. No concomitant medication was reported. The patient received meningococcal A, C, W-135, Y vaccine (unknown manufacturer, batch number: not reported) along with VARIVAX (batch number: H007450) on 13 Sep 2012. On 02 Dec 2012, the patient was found to be pregnant. The patient became pregnant with LMP (last menstrual period) of 01 Aug 2012 and EDD (estimated delivery date) on 08 May 2013. Initial exposure to VARIVAX was at 6 week. The pregnancy outcome was not reported. In 2012 (exact date unspecified) pregnancy test was done and the patient was pregnant. On 13 Sep 2012, PPD was performed, results not provided. The patient sought unspecified medical attention. No further information was available. This case was identified with a wrong pregnancy outcome during checks: As no more information was obtained, this prospective pregnancy was considered as lost to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness unilateral, Eye disorder
Clinical narrative: Information has been received from a pharmacist via field employee referring to a female patient of unknown age. There was no concurrent condition or medical history reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosage, strength, route of administration, lot # and expiration date were not reported). There was no concomitant medication reported. Subsequently, on an unknown date the patient touched the ZOSTAVAX injection site and then her eye, and developed unspecified eye issues on an unspecified date. The outcome of the eye issues was unknown. The relatedness between the event and ZOSTAVAX was not reported. Follow up information has been received from the pharmacist on 08-JAN-2016. It was stated that the patient received ZOSTAVAX on an unspecified date and approximately one month later (date unspecified) mentioned that she could not see out of one of her eyes. No further information was reported. Upon internal review the event of "she could not see out of one of her eyes" was considered as medically significant. Additional information has been requested. Event, seriousness and narrative were updated.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Amenorrhoea, Blood thyroid stimulating hormone normal, Differential white blood cell count normal, Full blood count normal, Headache
Clinical narrative: Pt. had never missed period prior to HPV vaccine. Pt. received HPV #1, missed a whole month of menstrual period, then started again (menstrual cycle). Pt received HPV #2, then pt got headache 2 days after HPV #2. Headache was continuous for 7 days (ended 11/11/15). Pt had menstrual period on 10/28/15 and 11/30/15. Per mom's report - 1st shot affected menstrual cycle, but the 2nd shot did not. Pt. has history of headaches off and on but none have lasted as long as 7 days.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lipids normal, Metabolic function test normal, Vitamin D
Clinical narrative: Pt. had never missed period prior to HPV vaccine. Pt. received HPV #1, missed a whole month of menstrual period, then started again (menstrual cycle). Pt received HPV #2, then pt got headache 2 days after HPV #2. Headache was continuous for 7 days (ended 11/11/15). Pt had menstrual period on 10/28/15 and 11/30/15. Per mom's report - 1st shot affected menstrual cycle, but the 2nd shot did not. Pt. has history of headaches off and on but none have lasted as long as 7 days.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood thyroid stimulating hormone normal, Differential white blood cell count normal, Full blood count normal, Headache, Lipids normal
Clinical narrative: Pt. had never missed period prior to HPV vaccine. Pt. received HPV #1, missed a whole month of menstrual period, then started again (menstrual cycle). Pt received HPV #2, then pt got headache 2 days after HPV #2. Headache was continuous for 7 days (ended 11/11/15). Pt had menstrual period on 10/28/15 and 11/30/15. Per mom's report - 1st shot affected menstrual cycle, but the 2nd shot did not. Pt. has history of headaches off and on but none have lasted as long as 7 days.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Menstruation delayed, Metabolic function test normal, Vitamin D
Clinical narrative: Pt. had never missed period prior to HPV vaccine. Pt. received HPV #1, missed a whole month of menstrual period, then started again (menstrual cycle). Pt received HPV #2, then pt got headache 2 days after HPV #2. Headache was continuous for 7 days (ended 11/11/15). Pt had menstrual period on 10/28/15 and 11/30/15. Per mom's report - 1st shot affected menstrual cycle, but the 2nd shot did not. Pt. has history of headaches off and on but none have lasted as long as 7 days.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Pt broke out in hives on chest and arms went to Dr.
Age: 45.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Cold sweat, Dehydration, Depressed level of consciousness, Diarrhoea, Dizziness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 45-year-old male patient who received ENGERIX B adult (batch number 9937B, expiry date 2nd October 2017). Concurrent medical conditions included gluten intolerance and food intolerance. Concomitant products included ARICEPT, omeprazole, warfarin, PROAIR Hfa, fluoxetine, CARTIA Xt, baclofen, dicyclomine and fluticasone nasal. On 15th December 2015, the patient received the 1st dose of ENGERIX B adult (intramuscular) 1 ml. On 16th December 2015, 1 days after receiving ENGERIX B adult, the patient experienced diarrhea, dizziness, nausea, headache, dehydration, cold sweat, skin bleeding and chapped skin. ENGERIX B adult was discontinued. On an unknown date, the outcome of the diarrhea, dizziness, nausea, headache, dehydration, cold sweat and chapped skin were recovered/resolved and the outcome of the skin bleeding was recovering/resolving. The reporter considered the diarrhea, dizziness, nausea, headache, dehydration and cold sweat to be related to ENGERIX B adult. It was unknown if the reporter considered the skin bleeding and chapped skin to be related to ENGERIX B adult. Additional details were received as follows: The patient received 1st dose of Hepatitis B vaccine as in ENGERIX B adult as he recently started a new job. The patient felt fine when he went to bed the night of vaccination, but early the next day he started experiencing severe diarrhea. The diarrhea was so bad he got very dehydrated no matter how much he was drinking. His knuckles became cracked and bleeding (skin cracked and skin bleeding) because of the dehydration. He also felt dizzy, like he would pass out a few times. He had cold sweats and headaches and felt very nauseous. He never threw up. The symptoms lasted about 3 days. thought it was all a blur due to how bad the patient was feeling so he cannot be certain. The patient did not get medical attention because he was not willing to miss work with his new job. If he didn't have to work he probably would have gone to the ER. The events have all resolved, but the patient was still has to treat his hands because they would still sometimes crack and bleed. The patient had recently learned that he was intolerant to soy and gluten, and wonders if that was related to his reaction. The patient would not be receiving any further Hepatitis B vaccines. He did not believe it was something infectious because none of the people he works with had gotten sick and he was at work during the worst part of the reaction.
Age: 45.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Haemorrhage, Headache, Nausea, Skin fissures
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 45-year-old male patient who received ENGERIX B adult (batch number 9937B, expiry date 2nd October 2017). Concurrent medical conditions included gluten intolerance and food intolerance. Concomitant products included ARICEPT, omeprazole, warfarin, PROAIR Hfa, fluoxetine, CARTIA Xt, baclofen, dicyclomine and fluticasone nasal. On 15th December 2015, the patient received the 1st dose of ENGERIX B adult (intramuscular) 1 ml. On 16th December 2015, 1 days after receiving ENGERIX B adult, the patient experienced diarrhea, dizziness, nausea, headache, dehydration, cold sweat, skin bleeding and chapped skin. ENGERIX B adult was discontinued. On an unknown date, the outcome of the diarrhea, dizziness, nausea, headache, dehydration, cold sweat and chapped skin were recovered/resolved and the outcome of the skin bleeding was recovering/resolving. The reporter considered the diarrhea, dizziness, nausea, headache, dehydration and cold sweat to be related to ENGERIX B adult. It was unknown if the reporter considered the skin bleeding and chapped skin to be related to ENGERIX B adult. Additional details were received as follows: The patient received 1st dose of Hepatitis B vaccine as in ENGERIX B adult as he recently started a new job. The patient felt fine when he went to bed the night of vaccination, but early the next day he started experiencing severe diarrhea. The diarrhea was so bad he got very dehydrated no matter how much he was drinking. His knuckles became cracked and bleeding (skin cracked and skin bleeding) because of the dehydration. He also felt dizzy, like he would pass out a few times. He had cold sweats and headaches and felt very nauseous. He never threw up. The symptoms lasted about 3 days. thought it was all a blur due to how bad the patient was feeling so he cannot be certain. The patient did not get medical attention because he was not willing to miss work with his new job. If he didn't have to work he probably would have gone to the ER. The events have all resolved, but the patient was still has to treat his hands because they would still sometimes crack and bleed. The patient had recently learned that he was intolerant to soy and gluten, and wonders if that was related to his reaction. The patient would not be receiving any further Hepatitis B vaccines. He did not believe it was something infectious because none of the people he works with had gotten sick and he was at work during the worst part of the reaction.
Age: 45.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Cold sweat, Dehydration, Diarrhoea, Dizziness, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 45-year-old male patient who received ENGERIX B adult (batch number 9937B, expiry date 2nd October 2017). Concurrent medical conditions included gluten intolerance and food intolerance. Concomitant products included ARICEPT, omeprazole, warfarin, PROAIR Hfa, fluoxetine, CARTIA Xt, baclofen, dicyclomine and fluticasone nasal. On 15th December 2015, the patient received the 1st dose of ENGERIX B adult (intramuscular) 1 ml. On 16th December 2015, 1 days after receiving ENGERIX B adult, the patient experienced diarrhea, dizziness, nausea, headache, dehydration, cold sweat, skin bleeding and chapped skin. ENGERIX B adult was discontinued. On an unknown date, the outcome of the diarrhea, dizziness, nausea, headache, dehydration, cold sweat and chapped skin were recovered/resolved and the outcome of the skin bleeding was recovering/resolving. The reporter considered the diarrhea, dizziness, nausea, headache, dehydration and cold sweat to be related to ENGERIX B adult. It was unknown if the reporter considered the skin bleeding and chapped skin to be related to ENGERIX B adult. Additional details were received as follows: The patient received 1st dose of Hepatitis B vaccine as in ENGERIX B adult as he recently started a new job. The patient felt fine when he went to bed the night of vaccination, but early the next day he started experiencing severe diarrhea. The diarrhea was so bad he got very dehydrated no matter how much he was drinking. His knuckles became cracked and bleeding (skin cracked and skin bleeding) because of the dehydration. He also felt dizzy, like he would pass out a few times. He had cold sweats and headaches and felt very nauseous. He never threw up. The symptoms lasted about 3 days. thought it was all a blur due to how bad the patient was feeling so he cannot be certain. The patient did not get medical attention because he was not willing to miss work with his new job. If he didn't have to work he probably would have gone to the ER. The events have all resolved, but the patient was still has to treat his hands because they would still sometimes crack and bleed. The patient had recently learned that he was intolerant to soy and gluten, and wonders if that was related to his reaction. The patient would not be receiving any further Hepatitis B vaccines. He did not believe it was something infectious because none of the people he works with had gotten sick and he was at work during the worst part of the reaction.
Age: 45.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Nausea, Skin fissures, Skin haemorrhage
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 45-year-old male patient who received ENGERIX B adult (batch number 9937B, expiry date 2nd October 2017). Concurrent medical conditions included gluten intolerance and food intolerance. Concomitant products included ARICEPT, omeprazole, warfarin, PROAIR Hfa, fluoxetine, CARTIA Xt, baclofen, dicyclomine and fluticasone nasal. On 15th December 2015, the patient received the 1st dose of ENGERIX B adult (intramuscular) 1 ml. On 16th December 2015, 1 days after receiving ENGERIX B adult, the patient experienced diarrhea, dizziness, nausea, headache, dehydration, cold sweat, skin bleeding and chapped skin. ENGERIX B adult was discontinued. On an unknown date, the outcome of the diarrhea, dizziness, nausea, headache, dehydration, cold sweat and chapped skin were recovered/resolved and the outcome of the skin bleeding was recovering/resolving. The reporter considered the diarrhea, dizziness, nausea, headache, dehydration and cold sweat to be related to ENGERIX B adult. It was unknown if the reporter considered the skin bleeding and chapped skin to be related to ENGERIX B adult. Additional details were received as follows: The patient received 1st dose of Hepatitis B vaccine as in ENGERIX B adult as he recently started a new job. The patient felt fine when he went to bed the night of vaccination, but early the next day he started experiencing severe diarrhea. The diarrhea was so bad he got very dehydrated no matter how much he was drinking. His knuckles became cracked and bleeding (skin cracked and skin bleeding) because of the dehydration. He also felt dizzy, like he would pass out a few times. He had cold sweats and headaches and felt very nauseous. He never threw up. The symptoms lasted about 3 days. thought it was all a blur due to how bad the patient was feeling so he cannot be certain. The patient did not get medical attention because he was not willing to miss work with his new job. If he didn't have to work he probably would have gone to the ER. The events have all resolved, but the patient was still has to treat his hands because they would still sometimes crack and bleed. The patient had recently learned that he was intolerant to soy and gluten, and wonders if that was related to his reaction. The patient would not be receiving any further Hepatitis B vaccines. He did not believe it was something infectious because none of the people he works with had gotten sick and he was at work during the worst part of the reaction.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abasia, Blood test normal, Erythema, Gait disturbance, Injection site erythema
Clinical narrative: Approximately three days after injection of PREVNAR 13, (11/20/2015), abnormal redness occurred at the site and continued to worsen. By 11/29/2015, area was red and swollen to bend of arm with warmth. Patient saw MD on that date and was given an antibiotic and an anti-inflammatory Rx. Redness and swelling cleared in about a week, but in the meantime, patient developed inability to walk and was seen in ER 1/3/2016. Tests were done and pathologically were negative. ER doctor said he could not rule out the vaccine and advised to continue meds and use a walker. Patient is still having difficulty walking and has to use a walker as an aid. Major weakness and inability to navigate stairs is still a problem as of this date, 1/12/2016. This is the first time patient has ever had any vaccine reaction. Please let me know the status of this situation and if any compensation is appropriate. I am the sister and have POA.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site swelling, Peripheral swelling, Scan normal, Skin warm, Walking aid user
Clinical narrative: Approximately three days after injection of PREVNAR 13, (11/20/2015), abnormal redness occurred at the site and continued to worsen. By 11/29/2015, area was red and swollen to bend of arm with warmth. Patient saw MD on that date and was given an antibiotic and an anti-inflammatory Rx. Redness and swelling cleared in about a week, but in the meantime, patient developed inability to walk and was seen in ER 1/3/2016. Tests were done and pathologically were negative. ER doctor said he could not rule out the vaccine and advised to continue meds and use a walker. Patient is still having difficulty walking and has to use a walker as an aid. Major weakness and inability to navigate stairs is still a problem as of this date, 1/12/2016. This is the first time patient has ever had any vaccine reaction. Please let me know the status of this situation and if any compensation is appropriate. I am the sister and have POA.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abasia, Asthenia, Blood test, Computerised tomogram, Gait disturbance
Clinical narrative: Approximately three days after injection of PREVNAR 13, (11/20/2015), abnormal redness occurred at the site and continued to worsen. By 11/29/2015, area was red and swollen to bend of arm with warmth. Patient saw MD on that date and was given an antibiotic and an anti-inflammatory Rx. Redness and swelling cleared in about a week, but in the meantime, patient developed inability to walk and was seen in ER 1/3/2016. Tests were done and pathologically were negative. ER doctor said he could not rule out the vaccine and advised to continue meds and use a walker. Patient is still having difficulty walking and has to use a walker as an aid. Major weakness and inability to navigate stairs is still a problem as of this date, 1/12/2016. This is the first time patient has ever had any vaccine reaction. Please let me know the status of this situation and if any compensation is appropriate. I am the sister and have POA.
Age: 70.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Ultrasound scan, Walking aid user
Clinical narrative: Approximately three days after injection of PREVNAR 13, (11/20/2015), abnormal redness occurred at the site and continued to worsen. By 11/29/2015, area was red and swollen to bend of arm with warmth. Patient saw MD on that date and was given an antibiotic and an anti-inflammatory Rx. Redness and swelling cleared in about a week, but in the meantime, patient developed inability to walk and was seen in ER 1/3/2016. Tests were done and pathologically were negative. ER doctor said he could not rule out the vaccine and advised to continue meds and use a walker. Patient is still having difficulty walking and has to use a walker as an aid. Major weakness and inability to navigate stairs is still a problem as of this date, 1/12/2016. This is the first time patient has ever had any vaccine reaction. Please let me know the status of this situation and if any compensation is appropriate. I am the sister and have POA.
Age: 79.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Abasia, Chills, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: The patient felt weak, vomited, got swollen itchy hands and then collapsed. He husband called 911 and when they arrived she was a bit better.
Age: 79.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Pain, Peripheral swelling, Pruritus, Somnolence, Syncope
Clinical narrative: The patient felt weak, vomited, got swollen itchy hands and then collapsed. He husband called 911 and when they arrived she was a bit better.
Age: 79.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Vomiting
Clinical narrative: The patient felt weak, vomited, got swollen itchy hands and then collapsed. He husband called 911 and when they arrived she was a bit better.
Age: 79.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Asthenia, Peripheral swelling, Pruritus, Syncope, Vomiting
Clinical narrative: The patient felt weak, vomited, got swollen itchy hands and then collapsed. He husband called 911 and when they arrived she was a bit better.