chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Minor HA and soreness the night of shot, redness and swelling at injection site. No itching, trouble breathing or hives. On 9/22/16 the patient presented with bruising and red spots on the under side (armpit area) of the injection site.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Started with redness on her arm below the vaccine site; spread downward on arm; on 9/21/16 was 6x4.5 inch warm hard red swollen area.  Top border of area was approx 1 inch below vaccination site.  Treated with cephalexin.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site oedema, Pain in extremity, Paraesthesia
Clinical narrative: Left deltoid edema/erythema, numbness/tingling/pain in the left arm, swelling down the arm to the hand.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: Left deltoid edema/erythema, numbness/tingling/pain in the left arm, swelling down the arm to the hand.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site swelling, Injection site erythema
Clinical narrative: Patient explained that about 3 days after receiving the Zostavax, her arm was very swollen and very red around the administration site.  She showed photos on her cell phone 9/22/16.  Patient said no other problems or complications occurred and that the problem completely cleared up.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Migraine, Oropharyngeal pain, Pain in extremity, Peripheral coldness
Clinical narrative: Cold hands, cold feet, throat pain, arm pain, migraine. He got better after taking a Benadryl and went to sleep. In the morning he still had symptoms as slight migraine and slight throat pain.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Agitation, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Nausea
Clinical narrative: SWEATING, AGITATION, NAUSEA, DIZZINESS REPORTED IMMEDIATELY AFTER ADMINISTRATION. SEATED PT FOR 15 MINUTES, GAVE GLASS OF WATER. PT WAS FINE AFTERWARDS.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Noticed pain in upper left arm upon lifting arm upwards, soreness, range of motion limited.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Dizziness, Nausea, Pyrexia
Clinical narrative: Patient experienced: Lightheadedness, fever, nausea, weakness.
Age: 9.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Cyanosis
Clinical narrative: Forearm with prominent superficial vasculature, fingers blue.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: Patient reported to the pharmacy window and stated she thought she was having an allergic reaction to the pneumovax vaccine. Upon physical evaluation, patient's arm was swollen and red from armpit level down to just above the elbow. Patient stated it did not hurt, or itch. Patient also stated she was not having any problems breathing and did not report swelling anywhere else on her body. Patient stated she noticed her arm swollen and red mid-day on 9/20/16 but had not taken anything for it as of the time of consult. Patient was instructed to take benadryl and call her pcp. Patient agreed to do so and left the pharmacy.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dyskinesia, Syncope
Clinical narrative: Faint with jerking.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site infection, Skin warm
Clinical narrative: Arm red and hot at touch.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: PREVNAR 13 was administered intramuscularly to right deltoid on 9/13. On 9/21 patient returned to pharmacy to report the adverse event. Course of events: Swelling, pain, erythema localized to injection site starting several hours following injection. Pt said that her arm was "swollen to the size of a grapefruit" by that evening. Also experienced fever and chills. Pt did seek medical attention which improved following a cortisone shot and oral prednisone. Upon presenting to pharmacy on 9/21, symptoms had resolved with the exception of mild erythema on her upper right arm which covered her shoulder and outer bicep. FLUZONE HD was coadministered at the same date/time as PREVNAR. FLUZONE HD was administed in the opposite deltoid relative to PREVNAR. FLUZONE HD was tolerated without incident.
Age: 41.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Erythema, Injection site hypersensitivity, Peripheral swelling
Clinical narrative: Pt said she had a allergic site reaction where she had the vaccination in her arm. The patient's arm was a little swollen and red.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose, Loss of consciousness
Clinical narrative: Passed out (lost consciousness) as I was leaving the doctor's office. Within about 10 minutes after receiving the vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Death, Lung cancer metastatic
Clinical narrative: This spontaneous report as received from a consumer refers to her 73 year old husband with complications from cancers and who was exposed to the agent Orange chemicals in a war. On an unspecified date "in late 2013", the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported) subcutaneously. The consumer stated that the patient was feeling quite well at the time of vaccination. The consumer reported that on an unknown date, the patient experienced lung cancer that spread quickly. The consumer stated that they could not get him enough treatment fast enough and in September 2014, the patient died, "about nine months after receiving ZOSTAVAX". The cause of death was reported as lung cancer. It was unknown if an autopsy was performed. Upon internal review lung cancer was considered to be medically significant. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt came in to pharmacy on 9/22/16 with a large red area on upper left arm that was warm to the touch, and pt felt as if it was burning. Pt stated the area had gotten larger and appeared 2 days after vaccine given.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site warmth, Pain, Peripheral swelling
Clinical narrative: Pt c/o body aches, arm swelling, hot to touch and red in color at injection site.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Muscular weakness, Pain in extremity
Clinical narrative: This patient received FLUZONE HD from pharmacy on 8/30/16. She reports symptoms of weakness and pain in (L) arm starting 9/1 lasting approximately 10d. Then weakness and pain (R) arm. She presented to clinic on 9/21/16 and I referred her to ER. Pt stated she has received flu shots x 35 years and never had any problem.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Pruritus, Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Red, blotchy rash all over body, hot, itching. Then given 50ml oral BENADRYL per v/o Dr. Pt then became cold all over body. Pt felt better within 45 mins and was driven home by spouse. Prednisone prescribed.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Red, blotchy rash all over body, hot, itching. Then given 50ml oral BENADRYL per v/o Dr. Pt then became cold all over body. Pt felt better within 45 mins and was driven home by spouse. Prednisone prescribed.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Pain
Clinical narrative: Had a bruise for about 3 weeks after immunization. Continued to have pain, and hurts to lay on arm. When deltoid muscle is tightened, patient is in pain.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Pain, Rash generalised, Rash pruritic
Clinical narrative: Full body rash, very itchy. Patient is experiencing achiness and diarrhea.
Age: 70.0
Sex: M
Vaccine: FLU3, TD
Symptoms: Aura, Nausea, Seizure
Clinical narrative: Nausea, Aura, seizure feeling coming on but no seizure.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, hot spot at injection site for 2 days.
Age: 56.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site cellulitis, Injection site infection
Clinical narrative: Injection site infection. Diagnosed by emergency department physician as cellulitis. Treatment for cellulitis was clindamycin 150 mg 2 capsule every 8 hours for 10 days.
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Unevaluable event
Clinical narrative: Patient was given BENADRYL cream.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness along vessel line of left UE, left deltoid was admin site. Soreness, tenderness, no nothing.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Case number PHEH2016US020214 is an initial spontaneous report received from physician on 09 Aug 2016. This report refers to 54 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with influenza virus vaccine (Unknown seasonal or pandemic, manufacturer: unknown, batch number: not reported) on an unknown date. On an unknown date, the patient had flu vaccine allergies. Outcome, seriousness and causality of the event were not reported.
Sex: M
Vaccine: FLUX
Symptoms: Adverse drug reaction, Hypersensitivity
Clinical narrative: Case number PHEH2016US018551 is an initial spontaneous report received from consumer on 13 Jul 2016. This report refers to 67 year old male patient. Medical history included allergic reaction to flu shots and concomitant medication were not reported. The patient was vaccinated with influenza vaccine (manufacturer: unknown, batch number: not reported) on an unknown date. On an unspecified date, the patient had drug reactions/allergies. Patient had allergic reaction to flu shots in the past and now refuses to get them. It was not reported which flu shot was administered in the past. The outcome of event was not reported. The causality of event was not reported. The seriousness of the event was reported as non serious. No further follow-up attempts were required.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Case number PHEH2016US016932 is an initial spontaneous report received from a pharmacy technician on 28 Jun 2016. This report refers to patient of unknown age and gender. Medical history and concomitant medication were not reported. The patient was vaccinated with Influenza vaccine ( Unknown seasonal or pandemic, manufacturer: unknown, batch number: not reported) on an unspecified date. On an unknown date, patient had unspecified allergic reaction to an unspecified flu vaccine. The outcome and causality of the event were not reported. The seriousness of the event was reported as non serious. Since the reporter contact details were not provided, no follow was possible. Hence, the case was considered as lost to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Case number PHEH2016US013040 is an initial spontaneous case received from a consumer via pharmaceutical company (Mfr number:2016144094) on 23 May 2016. This report refers to a 55 year old male patient. Concomitant medication was not reported. The patient was allergic to aspirin (manufacturer unknown), BENADRYL, ibuprophen (manufacturer unknown), morphine sulphate (manufacturer unknown), ZOFRAN, penicillin, egg, dicyclomine, TYLENOL, SINGULAIR. The patient was vaccinated with influenza virus vaccine (manufacturer unknown, batch number: not reported) on an unknown date. On an unspecified date, patient had allergy to flu  vaccine. The outcome, seriousness and causality of event were not reported.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site reaction, Nausea
Clinical narrative: Patient has 2 inch wide band going around arm approximately 2 inches lower than injection site. Complains of nausea.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever 102.9 - given TYLENOL and MOTRIN, resolved.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Swollen, red, warm injection site consistent with local shot reaction.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain on left upper extremity 3 days post Pneumococcal vaccine. Erythema 3 inches below site of injection, warm to touch, mildly swollen. Diphenhydramine HCL 25mg tab, take 50mg PO every 6hrs PRN.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS, VARZOS
Symptoms: Back pain, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient reported area of redness and mild pain on the back left arm about 1 inch on 9/21 and increased to redness and swelling with mild pain and warmth along the entire length of the back of the arm.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reported area of redness and mild pain on the back left arm about 1 inch on 9/21 and increased to redness and swelling with mild pain and warmth along the entire length of the back of the arm.
Age: 82.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Rash, Swelling
Clinical narrative: Right arm rash, swelling and pink. Pain started 9/21/16.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Patient received Quad flu vaccine (by GSK) at 11:00AM 9/20/16 at her place of employment. That night she noticed some swelling at injection site but on Wed morning swelling has spread down her arm to her elbow. Patient stated site was cleansed with alcohol and injection was given 2-3 inches down from top of shoulder. Patient tried ice but had not resolved. Called office 9/22 and instructed OTC ADVIL or TYLENOL and continue ice. MD notified and no further tx needed.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: 9/20/2016 12:30p Patient received flu vaccine and reported a rash on chest and neck, no hives, no swelling. Pt declined treatment with BENADRYL. VS were normal. Pt took own supply of ZYRTEC and oral BENADRYL and stayed with nurse for 30 more minutes without further issues. Pt reported back at 2:40p 9/20/16 that rash improved.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Rash
Clinical narrative: Had flu shot Monday 9/19/16 at her work. In evening at home noticed shot area had redness and rash and sore to touch. Called us 2 days later at office to report to us and tell us it was getting better. Recommended ice, ADVIL and BENADRYL and tell her physician.
Age: 68.0
Sex: M
Vaccine: DTPIPV
Symptoms: Oedema peripheral, Pruritus, Rash
Clinical narrative: Rash, pruritus, edema of arm.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Employee received FLULAVAL vaccine on 9/19/2016 and the morning broke out in a red itchy rash and hives on arms, neck, face, back and knees.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Employee received FLULAVAL vaccine on 9/19/2016 and the morning broke out in a red itchy rash and hives on arms, neck, face, back and knees.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Decreased appetite, Myalgia, Sleep disorder, Vomiting
Clinical narrative: Received FLUZONE HIGH-DOSE 0.5 ML syr on 9/17/16. Could not sleep all night because of muscle and bone aches. At 6:00am on 6/18 woke up and vomited. Experienced no appetite entire day along with muscle and bone aches. At approx. 8:30pm on 6/18 it all went away. I have never had a reaction to the flu vaccine in the past.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Papilloma viral infection
Clinical narrative: This spontaneous report referring a 12 year old female patient was received from the patient's mother. It was also reported that the patient received other immunizations outside of the recommended time frame. On 02-NOV-2007, the patient was vaccinated with the first dose of GARDASIL (also reported as GARDASIL 9) (lot number, expiration date, dose, strength and route of administration were not reported). On 04-AUG-2016, the patient was vaccinated with the second and third dose of GARDASIL respectively. There were no concomitant medications reported. On an unknown date the patient experienced HPV. The reporter stated that the patient's second dose was not given in the recommended time frame and therefore may be the cause for her daughter developed a "small strain of HPV". No treatment was given for the event, and no product quality complain was involved. The reporter stated that her daughter would be seeing by a physician to assess and treat the HPV. At the reporting time, the outcome of the event was not recovered and the reporter did not assess the relationship between the event GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and genders. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. Approximately in 2016 (reported as "starting 23-AUG-2016 to present, 08-SEP-2016"), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB which had a lot # of M022077, with an expiration date of 10-MAR-2019 and lot # of M006708 and an expiration date of 02-JUN-2018 (route, concentration, dose number, dose and anatomical place of vaccination were not provided). Which were exposed to a temperature of 0.3 C for 5 hours and 5 minutes, and a data logger was involved. Nevertheless, no adverse effects were reported and no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Nightmare, Skin discolouration
Clinical narrative: Patient claims to have black and blue arm and bad dreams. Reported 9/21/16.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Pt. forgot she had already received a PREVENAR - 13 shot from her MD and received another one from us on 8/29/16. The one from the MD was administered on 11/4/15.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Skin infection
Clinical narrative: Pt stated R arm became itchy and red with lump at injection site. Went to urgent care 9-15-16 Dx with skin infection given ABT per P/C.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose decreased, Blood insulin, Dizziness, Electrocardiogram normal, Fatigue
Clinical narrative: Symptoms started about 8 days after vaccinated. Symptoms include hands and feet tingling, dizziness, syncope, fatigue. Has had several episodes of syncope and low blood sugar.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Paraesthesia, Syncope
Clinical narrative: Symptoms started about 8 days after vaccinated. Symptoms include hands and feet tingling, dizziness, syncope, fatigue. Has had several episodes of syncope and low blood sugar.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Patient had fever, nausea, redness, bruising sensitive to touch, extreme pain at the injection site, pain on arm, swelling at inj site, about 2 inch area was red and 1 inch was bruised. Patient went to urgent care to get pain med and was prescribed ibuprofen 600 mg TID.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient had fever, nausea, redness, bruising sensitive to touch, extreme pain at the injection site, pain on arm, swelling at inj site, about 2 inch area was red and 1 inch was bruised. Patient went to urgent care to get pain med and was prescribed ibuprofen 600 mg TID.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong drug administered
Clinical narrative: PEDIARIX given, DTaP ordered.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date in 2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M000761, expiration date: 06-JAN-2016, 0.5 ml, (route of administration was not provided), after a temperature excursion at 8 Fahrenheit degrees, for 12 hours on 18-MAY-2016. No previous temperature excursions were reported. Patient's concomitant medication was not reported. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Age: 0.58
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 8 months old female patient. No information regarding the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was provided. On 02-AUG-2016 at 14:30, the patient was vaccinated with an improperly stored third dose of ROTATEQ lot # L039141 and expiration date 16-AUG-2017, (Strength and dose were not reported), via oral. It was reported that the vaccine was exposed to a temperature excursion described as a minimum (MIN) of 33 Fahrenheit (F) degrees for 10 minutes and a maximum (MAX) of 48 F degrees for 10 minutes. The healthcare worker also stated that the MIN and MAX were not cleared previously. No previous temperature excursion was noted. Patient's concomitant medication was not provided. No adverse effects were reported. A product quality complaint was not involved. This is one of the several reports received from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # was reported as M002218, expiration date 03-SEP-2017; dose and route were unknown). No adverse effects was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Malaise, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Information has been received from a healthcare worker via a company representative referring to 3 patients of unknown ages and genders with asthma. Each patient was concomitantly placed on inhaled corticosteroids. On an unknown date, each of the three patients was vaccinated with a dose of PNEUMOVAX 23 (dose and route unknown, lot # L034335, expiration date: 18-MAY-2017) in a arm. On the same date as receiving the PNEUMOVAX 23, each patient also received a dose of a influenza virus vaccine (unspecified)(brand name and manufacturer unknown) into the same arm where the PNEUMOVAX 23 was injected. On unknown dates, each patient developed fever, swollen arms, body aches, and malaise. The patients called a pharmacist to seek medical attention. These problems lasted for 4 days in each patient before each patient recovered (recovery dates unknown). The causal relationship between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacy intern referring to a patient of unknown age and gender. On 06-SEP-2016 the patient was vaccinated with expired PNEUMOVAX 23 lot # L002310 (expiration date 08-JUL-2016). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacy intern referring to 2 patients of unknown age and gender. On unknown dates in 2016 the patients were vaccinated with expired PNEUMOVAX 23 lot # L002310 (expiration date 08-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified patient of unknown age and gender. There was no information regarding concomitant medication, medical history or drug reactions/allergies. On an unknown date, the patient was vaccinated with an improperly stored dose of VAQTA 25/0.5 (unit not provided) injection (lot # M011116 with expiration date 17-JUN-2017; dose unknown; intramuscular). The vaccine was improperly stored at 31 Fahrenheit for 48 hours. There was no previous excursion. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect dose administered, Needle issue, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 07-SEP-2016, during the administration of single-dose vial of GARDASIL 9 lot # M018810 (expiration date 28-MAY-2018), intramuscularly to the patient, some of the vaccine leaked out of the needle and onto the patient's arm. Nurse put a new needle on the syringe and attempted to administer the rest of the dose in a separate injection, but she could not advance the plunger. This resulted in administration of a partial dose of GARDASIL 9, which nurse reported she felt was "about 0.4 ml". No adverse effect was reported. The outcome of the adverse events was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. On an unknown dates, the patient was vaccinated with a series of an unspecified HPV vaccine (manufacturer unknown) (lot #, expiration date were not reported). On an unknown dates since completion of the first series, the patient received 2 doses of GARDASIL 9 (lot #, expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L017143, expiration date 13-MAY-2017; lot # L024250, expiration date 30-JUN-2017; lot # L048465, expiration date 02-DECY-2017; lot # L050560, expiration date 14-DEC-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -9.9 degrees Celsius for 14 hours. There were previous excursions of -11 degrees Celsius for 4 hours, -13.1 degrees Celsius for 5 days, -13.6 degrees Celsius for 14 days, -12 degrees Celsius for 2 days, -13.9 degrees Celsius for 3 days, -13.1 degrees Celsius for 5 days, -13 degrees Celsius for 7 days, -11.1 degrees Celsius for 2 days, -12.2 degrees Celsius for 9 days, -14 degrees Celsius for 9 days, -11.1 degrees Celsius for 1 day, -12.8 degrees Celsius for 10 days, -14.6 degrees Celsius for 1 day, -14.2 degrees Celsius for 4 days, -14.6 degrees Celsius for 1 day, -14.8 degrees Celsius for 3 days, -14 degree Celsius for 10 days, -13.7 degrees Celsius for 1 day. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # L023112, expiration date 24-DEC-2016; lot # L041627, expiration date 20-APR-2017; lot # L047305, expiration date 23-MAY-2017; lot # M002058, expiration date 11-JUL-2017; lot # M018638, expiration date 11-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -9.9 degrees Celsius for 14 hours. There were previous excursions of -11 degrees Celsius for 4 hours, -13.1 degrees Celsius for 5 days, -13.6 degrees Celsius for 14 days, -12 degrees Celsius for 2 days, -13.9 degrees Celsius for 3 days, -13.1 degrees Celsius for 5 days, -13 degrees Celsius for 7 days, -11.1 degrees Celsius for 2 days, -12.2 degrees Celsius for 9 days, -14 degrees Celsius for 9 days, -11.1 degrees Celsius for 1 day, -12.8 degrees Celsius for 10 days, -14.6 degrees Celsius for 1 day, -14.2 degrees for 4 days, -14.6 degrees Celsius for 1 day, -14.8 degrees Celsius for 3 days, -14 degrees Celsius for 10 days, -13.7 degrees Celsius for 1 day. This is one of several reports received 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 certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. On 20-SEP-2016, the patient was vaccinated with a expired dose ZOSTAVAX with lot # L021609 and expiration date 10-SEP-2016; 0.65 ml, via subcutaneous route. No adverse effects reported. No product quality complaint was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 20-SEP-2016, the patient was vaccinated with properly stored expired dose of PROQUAD (lot # L009209, expiry date: 17-SEP-2016), (route: subcutaneous) (expired product administered). No adverse reactions reported. The outcome of the events was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPVX
Symptoms: Adverse event, Incorrect product storage
Clinical narrative: This spontaneous report was received from an 18 year old female patient's mother. The reporter noticed that out of the 3 doses her daughter received, one of the doses was GARDASIL and the rest were GARDASIL 9. She was not sure if this was a data entry error from the Pediatrician's office. It was also reported that the patient experienced an adverse event (details unspecified) after receiving GARDASIL. The outcome of the event was unknown. No product quality complaint was involved. Additional information is not expected as the reporter declined to participate with the report.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as Office Manager) referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (dosing details unspecified) (lot # K015463, expiry date: 09-JUL-2017; lot # L014429, expiry date: 15-MAR-2018; lot # M001814, expiry date: 15-JAN-2018). No adverse effects were reported. It was reported that vaccines were not discontinued. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a family nurse practitioner, and refers to a 10 month old patient of unknown gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 19-SEP-2016 , the patient was inadvertently vaccinated with an adult dose of RECOMBIVAX HB intramuscularly, lot # M001579 with expiration date 05-OCT-2018 (dose and frequency were not reported). No concomitant medications, adverse effects or product quality complaints were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 06-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 intramuscularly (dose was not reported; lot # L038503 with an expiration date on 18-DEC-2017). Administered dose of GARDASIL 9 was exposed to the temperature of 33.9 Fahrenheit degrees for 34 minutes, on an unknown date. There was no information about previous temperature excursion or digital data logger. No adverse effects were observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as Office Manager) referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored GARADASIL 9 injection (dosing details unspecified) (lot # L037554, expiry date: 25-DEC-2017; lot # M011840, expiry date: 01-FEB-2018). No adverse effects were reported. It was reported that vaccines were not discontinued. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. Approximately in 2016 (reported as "starting 23-AUG-2016 to present, 08-SEP-2016"), the patients were vaccinated with improperly stored doses of VAQTA, which had a lot # of M002268, with an expiration date of 20-SEP-2017 (route, concentration, dose number, dose and anatomical place of vaccination were not provided). Which were reported because of data logger. Nevertheless, no adverse effects were reported and no product quality complaint was involved. This is one of several reports 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 and refers to a unspecified number of patients of unknown age and genders. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. Approximately in 2016 (reported as "starting 23-AUG-2016 to present, 08-SEP-2016"), the patients were vaccinated with improperly stored doses of GARDASIL which had a lot # of L035105, and an expiration date of 14-MAY-2017 (concentration, route, dose number, dose and anatomical place of vaccination were not provided). Which were exposed to a temperature of 1.5 C for 21 minutes, and a data logger was involved. Nevertheless, no adverse effects were reported and no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Headache, Influenza virus test negative, Pyrexia
Clinical narrative: Received Imm 9/17/16 11 AM and at 3 PM same day c/o HA. Dizziness, chills, fever. Symptoms continued thru 9/20/16. Seen at clinic on 9/19/16 and OV on 9/21/16 - resolved.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Streptococcus test negative
Clinical narrative: Received Imm 9/17/16 11 AM and at 3 PM same day c/o HA. Dizziness, chills, fever. Symptoms continued thru 9/20/16. Seen at clinic on 9/19/16 and OV on 9/21/16 - resolved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 14-SEP-2016, the patient was vaccinated with an expired dose of M-M-R II (Lot# K020189, expiration date 11-SEP-2016) (Dose and route were not provided). Concomitant medications was not reported. The patient had not reported an adverse experience. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Local reaction, Swelling
Clinical narrative: Local reaction swelling 8x10 cm. Tx cold packs 15-20mins next 2-3 days. BENADRYL at bedtime 25mg, ZYRTEC 10mg day time. Follow up 48 hours if not better.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant medication were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (which had the lot # M008173, expiration date 16-FEB-2018) (dose and anatomical site of vaccination was not reported). The temperature excursion for this lot was 6 hours at 14.3 C. No adverse reaction were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and genders. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. Approximately in 2016 (reported as "starting 23-AUG-2016 to present, 08-SEP-2016"), the patients were vaccinated with improperly stored doses of GARDASIL 9 which had a lot # of M011117, with an expiration date of 07-DEC-2017 and lot # of L043214 and an expiration date of 30-AUG-2017 (concentration, route, dose number, dose and anatomical place of vaccination were not provided). Which were reported because a data logger. Nevertheless, no adverse effects were reported and no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Patient advised she is still having a lot of pain and discomfort in her arm after receiving the injection back on 9/13/2016. She sought medical care and was prescribed muscle relaxer.
Age: 40.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Diarrhoea, Immediate post-injection reaction, Malaise, Nausea
Clinical narrative: Started feeling sick immediately post vaccination - developed nausea, vomiting, diarrhea, weakness x 2 weeks.
Age: 40.0
Sex: M
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: Started feeling sick immediately post vaccination - developed nausea, vomiting, diarrhea, weakness x 2 weeks.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Dizziness, Hypertension, Nervousness
Clinical narrative: This spontaneous report was received from a 22 year old female pharmacy technician reporting on herself. the patient's pertinent medical history was not reported. The patient did not have any drug/allergic reactions and concomitant medications. On 19-AUG-2016, she was vaccinated with third dose of GARDASIL 9 on her left arm subcutaneously (dose, strength, frequency, date of expiry and lot# were not reported). On the same day, 20 minutes later she became lightheaded, began shaking, she became nauseous and anxious. Her blood pressure was 151/112 (units unspecified). She went to emergency room where she was diagnosed as anaphylactic shock. She received unspecified treatment for the adverse event and was in the emergency room for 3 hours. She recovered from the anaphylactic shock. The reporter did not provide the relatedness of the event with GARDASIL 9. Upon internal review "anaphylactic shock" was considered to be medically significant. 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 22 year old female pharmacy technician reporting on herself. the patient's pertinent medical history was not reported. The patient did not have any drug/allergic reactions and concomitant medications. On 19-AUG-2016, she was vaccinated with third dose of GARDASIL 9 on her left arm subcutaneously (dose, strength, frequency, date of expiry and lot# were not reported). On the same day, 20 minutes later she became lightheaded, began shaking, she became nauseous and anxious. Her blood pressure was 151/112 (units unspecified). She went to emergency room where she was diagnosed as anaphylactic shock. She received unspecified treatment for the adverse event and was in the emergency room for 3 hours. She recovered from the anaphylactic shock. The reporter did not provide the relatedness of the event with GARDASIL 9. Upon internal review "anaphylactic shock" was considered to be medically significant. 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 22 year old female pharmacy technician reporting on herself. the patient's pertinent medical history was not reported. The patient did not have any drug/allergic reactions and concomitant medications. On 19-AUG-2016, she was vaccinated with third dose of GARDASIL 9 on her left arm subcutaneously (dose, strength, frequency, date of expiry and lot# were not reported). On the same day, 20 minutes later she became lightheaded, began shaking, she became nauseous and anxious. Her blood pressure was 151/112 (units unspecified). She went to emergency room where she was diagnosed as anaphylactic shock. She received unspecified treatment for the adverse event and was in the emergency room for 3 hours. She recovered from the anaphylactic shock. The reporter did not provide the relatedness of the event with GARDASIL 9. Upon internal review "anaphylactic shock" was considered to be medically significant. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Pain, Vaccination complication
Clinical narrative: This case was reported by a other health professional via a call center representative and described the occurrence of erythema in a 45-year-old female patient who received FLUARIX QUADRIVALENT (batch number 27P57, expiry date 30th June 2017). Previously administered products included FLUARIX (received in years past without adverse events). Concomitant products included omeprazole, terbinafine, and  WELLBUTRIN. On 13th September 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular). On 13th September 2016, less than an hour after receiving FLUARIX QUADRIVALENT, the patient experienced erythema, feeling of warmth, discomfort and swelling. The patient was treated with Prednisone. On an unknown date, the outcome of the erythema, feeling of warmth, discomfort and swelling were not recovered/not resolved. The reporter considered the erythema, feeling of warmth, discomfort and swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received TWINRIX adult on the left arm. On 13th September 2016, at 8:30 hours, the patient received FLUARIX QUADRIVALENT on the left arm. After receiving the vaccination, within 15 minutes, the patient was red, warmth and had discomfort and swelling. The patient returned to work in the morning with worsening of the symptoms and was sent to urgent care. The reporter was a staff assistant at the health department where vaccination was given.
Age: 45.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Discomfort, Erythema, Feeling hot, Swelling
Clinical narrative: This case was reported by a other health professional via a call center representative and described the occurrence of erythema in a 45-year-old female patient who received FLUARIX QUADRIVALENT (batch number 27P57, expiry date 30th June 2017). Previously administered products included FLUARIX (received in years past without adverse events). Concomitant products included omeprazole, terbinafine, and  WELLBUTRIN. On 13th September 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular). On 13th September 2016, less than an hour after receiving FLUARIX QUADRIVALENT, the patient experienced erythema, feeling of warmth, discomfort and swelling. The patient was treated with Prednisone. On an unknown date, the outcome of the erythema, feeling of warmth, discomfort and swelling were not recovered/not resolved. The reporter considered the erythema, feeling of warmth, discomfort and swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received TWINRIX adult on the left arm. On 13th September 2016, at 8:30 hours, the patient received FLUARIX QUADRIVALENT on the left arm. After receiving the vaccination, within 15 minutes, the patient was red, warmth and had discomfort and swelling. The patient returned to work in the morning with worsening of the symptoms and was sent to urgent care. The reporter was a staff assistant at the health department where vaccination was given.
Age: 35.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of numbness in feet in a 35-year-old male patient who received BOOSTRIX (batch number EC9A9, expiry date 22nd January 2019). Concomitant products included ibuprofen. On 12th September 2016, the patient received BOOSTRIX (intramuscular). On 13th September 2016, 1 days after receiving BOOSTRIX, the patient experienced numbness in feet. On an unknown date, the outcome of the numbness in feet was unknown. The reporter considered the numbness in feet to be almost certainly related to BOOSTRIX. Additional details were reported as follows: The physician reported that the patient experienced numbness in left pedal digits 3 and 4. The numbness was increased to include pedal digits number 3, 4, and 5. On 14th September 2016, the patient also began to experience numbness in their left palm. The reporter repeated the pedal digits, and the doctor affirmed pedal digits.
Age: 40.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Dizziness, Dyspnoea, Muscular weakness, Nausea, Paraesthesia
Clinical narrative: Flushing, dizziness, parasthesia of arms/hands, coughing, tightness of chest.