chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Erythema, Local reaction, Pain, Peripheral swelling
Clinical narrative: The patient has warm swelling in the left arm. The swelling is associated with generalized weakness, skin discoloration and warmth. The patient denies any bleeding. Following PPV23 injection in left deltoid. Warmth, erythema, swelling, pain pt states. Assessment Local reaction to pneumococcal vaccine, Initial encounter (TS0.A95A). Patient Plan start KEFLEX. Stop HIPREX while on KEFLEX then restart after completing KEFLEX.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin discolouration, Skin warm
Clinical narrative: The patient has warm swelling in the left arm. The swelling is associated with generalized weakness, skin discoloration and warmth. The patient denies any bleeding. Following PPV23 injection in left deltoid. Warmth, erythema, swelling, pain pt states. Assessment Local reaction to pneumococcal vaccine, Initial encounter (TS0.A95A). Patient Plan start KEFLEX. Stop HIPREX while on KEFLEX then restart after completing KEFLEX.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Nausea, Tinnitus, Vertigo
Clinical narrative: Pt reported that 5 days after receiving flu shot she experienced severe vertigo, severe nausea which kept her out of work for 3 days. This was accompanied by severe ringing in her ears.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Deafness unilateral, Dizziness
Clinical narrative: Pt reported that 3 days after receiving Flu shot she experienced feeling hearing loss on Rt side feeling off balance and dizzy.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Mobility decreased, Myalgia
Clinical narrative: Initial unsolicited report received from a pharmacist on 20 Oct 2017. This case involves a 72-year-old female patient who was vaccinated with one dose of FLUZONE HD (Batch number, expiry date, dose and dose in series were not reported) intramuscularly in left arm on 10-Oct-2017. Patient medical history was not reported. Concomitant medications were not reported. (It was reported as the patient was not taking any other vaccines). On 10-Oct-2017, immediately after the vaccination, the patient experienced severe muscle pain and cannot able to lift the arm or move it. On an unknown date, the patient was seen by a physician as her conditions was not improved and was prescribed with ALEVE PRN. It was reported as the patient was previously vaccinated with FLUZONE HD (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date in the past without any issues. Relevant lab tests were not reported. Other corrective treatment was not reported. The outcome of the events were reported as unknown List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Seizure
Clinical narrative: Initial unsolicited case received from a consumer (office staff) on 21 Nov 2017. This case involves 12-year-old patient (gender not reported) who was vaccinated with a dose of DAPTACEL (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, patient developed seizure. Relevant lab tests and corrective treatment were not reported. Outcome of the event was not reported. The case was reported as serious by the reporter due to medically significant event. List of documents held by sender: none. Sender's Comments: 12 year old Patient had a seizure after getting DAPTACEL. Time to onset compatibility is unknown. Further information including patient's medical history, concurrent medical condition, any seizure disorder, concomitant medications, previous vaccination, concurrent infection and tolerance would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: Erythema, edema, pruritis and pain at the site of the injection. Reaction area covers upper arm (deltoid and biceps). Patient was evaluated by PCP for the reaction and was asked to take over the counter antihistamine. Dr. advised patient to return to the Clinic and report reaction.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abnormal behaviour, Autism spectrum disorder, Decreased eye contact, Disability, Immediate post-injection reaction
Clinical narrative: Patient was a perfectly healthy and bright 15 MO. After these shots he immediately withdrew, stopped making eye contact, stopped feeding himself, stopped pointing, lost all his language, started spinning or lining up everything. He was diagnosed with autism and speech impairment at age 5. I am 100% certain that my son was injured by the MMR and/or the chicken pox vaccine at 15 mo. He is now 21 and receives benefits as he has a disability caused by these vaccines. He will have to live with us forever. There is no autism on either side of our family and our other 3 children are neurotypical. My husband's IQ is 134 and mine is 137. I had a perfectly healthy pregnancy and patient was almost 10 pounds at birth.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Laboratory test, Language disorder, Social avoidant behaviour, Speech disorder
Clinical narrative: Patient was a perfectly healthy and bright 15 MO. After these shots he immediately withdrew, stopped making eye contact, stopped feeding himself, stopped pointing, lost all his language, started spinning or lining up everything. He was diagnosed with autism and speech impairment at age 5. I am 100% certain that my son was injured by the MMR and/or the chicken pox vaccine at 15 mo. He is now 21 and receives benefits as he has a disability caused by these vaccines. He will have to live with us forever. There is no autism on either side of our family and our other 3 children are neurotypical. My husband's IQ is 134 and mine is 137. I had a perfectly healthy pregnancy and patient was almost 10 pounds at birth.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Patient presented for second dose of Hepatitis A series, inadvertently received extra dose of MCV-4 which was not forecasted. This writer contacted mother of patient on 12/4/17 regarding incident; mother has rescheduled patient to received scheduled Hep A vaccine. Mother reports no adverse reactions.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Injection site reaction, Pain, Pyrexia
Clinical narrative: Severe site reaction requiring urgent medical care 12/1/17: treated with steroid injection & BACTRIM po, resolved in 72hrs. Fever, chills, body pain: self treated with TYLENOL.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Injection site rash, Urticaria
Clinical narrative: Developed a rash around injection site on L arm. Mom says she had the bandage on until this AM. Not itchy. He currently has a headache. 8 yo male w/ urticarial rash surrounding flu vaccine site.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Abnormal behaviour, Allergy test, Alopecia, Antinuclear antibody positive
Clinical narrative: Patient had the HPV vaccine in a series of 3 shots - 6/22/15 - shot 1 - after that shot became extremely tired, started losing hair & was acting differently - not focusing. 1/12/16 shot #2 - continued to be tired and got real sick with bad headache, feverish and back neck pain - went into ER in Feb 2016 with what they thought was a bad virus - possibly viral meningitis. Bad headaches got better after a few weeks but still gets a lot of headaches and neck pain. 7/14/16 - shot #3 - On 7/18 she became extremely sick - Bad stomach pain, bad headache, extreme fatigue - stayed in bed, mind was "foggy". She has been the same ever since - we have been to several doctors to find out what is wrong and to get treated.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Blood test abnormal, Blood urine present, Borrelia test positive, Computerised tomogram abdomen
Clinical narrative: Patient had the HPV vaccine in a series of 3 shots - 6/22/15 - shot 1 - after that shot became extremely tired, started losing hair & was acting differently - not focusing. 1/12/16 shot #2 - continued to be tired and got real sick with bad headache, feverish and back neck pain - went into ER in Feb 2016 with what they thought was a bad virus - possibly viral meningitis. Bad headaches got better after a few weeks but still gets a lot of headaches and neck pain. 7/14/16 - shot #3 - On 7/18 she became extremely sick - Bad stomach pain, bad headache, extreme fatigue - stayed in bed, mind was "foggy". She has been the same ever since - we have been to several doctors to find out what is wrong and to get treated.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Cytogenetic analysis, Disturbance in attention, Endocrine test normal, Endoscopy gastrointestinal, Endoscopy upper gastrointestinal tract
Clinical narrative: Patient had the HPV vaccine in a series of 3 shots - 6/22/15 - shot 1 - after that shot became extremely tired, started losing hair & was acting differently - not focusing. 1/12/16 shot #2 - continued to be tired and got real sick with bad headache, feverish and back neck pain - went into ER in Feb 2016 with what they thought was a bad virus - possibly viral meningitis. Bad headaches got better after a few weeks but still gets a lot of headaches and neck pain. 7/14/16 - shot #3 - On 7/18 she became extremely sick - Bad stomach pain, bad headache, extreme fatigue - stayed in bed, mind was "foggy". She has been the same ever since - we have been to several doctors to find out what is wrong and to get treated.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Feeling abnormal, Headache, Immunology test, Laboratory test abnormal
Clinical narrative: Patient had the HPV vaccine in a series of 3 shots - 6/22/15 - shot 1 - after that shot became extremely tired, started losing hair & was acting differently - not focusing. 1/12/16 shot #2 - continued to be tired and got real sick with bad headache, feverish and back neck pain - went into ER in Feb 2016 with what they thought was a bad virus - possibly viral meningitis. Bad headaches got better after a few weeks but still gets a lot of headaches and neck pain. 7/14/16 - shot #3 - On 7/18 she became extremely sick - Bad stomach pain, bad headache, extreme fatigue - stayed in bed, mind was "foggy". She has been the same ever since - we have been to several doctors to find out what is wrong and to get treated.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Microbiology test, Neck pain, Protein urine present, Pyrexia
Clinical narrative: Patient had the HPV vaccine in a series of 3 shots - 6/22/15 - shot 1 - after that shot became extremely tired, started losing hair & was acting differently - not focusing. 1/12/16 shot #2 - continued to be tired and got real sick with bad headache, feverish and back neck pain - went into ER in Feb 2016 with what they thought was a bad virus - possibly viral meningitis. Bad headaches got better after a few weeks but still gets a lot of headaches and neck pain. 7/14/16 - shot #3 - On 7/18 she became extremely sick - Bad stomach pain, bad headache, extreme fatigue - stayed in bed, mind was "foggy". She has been the same ever since - we have been to several doctors to find out what is wrong and to get treated.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Red blood cell count decreased, Serum ferritin decreased, Urine analysis, Vitamin D decreased, White blood cell count increased
Clinical narrative: Patient had the HPV vaccine in a series of 3 shots - 6/22/15 - shot 1 - after that shot became extremely tired, started losing hair & was acting differently - not focusing. 1/12/16 shot #2 - continued to be tired and got real sick with bad headache, feverish and back neck pain - went into ER in Feb 2016 with what they thought was a bad virus - possibly viral meningitis. Bad headaches got better after a few weeks but still gets a lot of headaches and neck pain. 7/14/16 - shot #3 - On 7/18 she became extremely sick - Bad stomach pain, bad headache, extreme fatigue - stayed in bed, mind was "foggy". She has been the same ever since - we have been to several doctors to find out what is wrong and to get treated.
Age: 19.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: HPV 9 IM given in the right deltoid. Lot number M009116. Patient Reaction: Patient states she "sees stars" then passed out for approximately 5 seconds. Patient in sitting position. Father present. Patient roused and immediately states "I am okay." Cool rag obtained and applied to forehead and base of neck. Vital signs obtained. Temp 98.7, Pulse: 62, O2: 98, Blood pressure 100/66. Patient states "I just passed out, I have done this before when I tore my ACL." Patient given water to drink and monitored for 30 additional minutes. 10 in clinical area and 20 in lobby. Patient drank 16 ounces of water and told her father she felt fine. Father told her it was alright to go before I came back to check on patient. Father and patient have copy of VIS forms and instructions for "after the shots," VIS forms state what to do for additional symptoms, including when to seek medical help. Patient left with Sister, no distress noted by Secretary who was in the lobby when patient left. Follow up call made to father @ 1651 who states patient is well with no adverse reactions nor distress noted at this time.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: On 12/6/17 pt showed RN photo of her arm 2 days after Flu vaccine given on 11/7/17.  Local reaction and bruising noted. Pt says reaction started 1-2 days after injection and lasted several days. Noted at site of injection bruised area, size of a quarter coin. Approx 2" below injection site, red area covered 1/3 of upper outer arm - pt said it was swollen and felt hot.
Age: 52.0
Sex: M
Vaccine: HEP, HIBV, IPV, MNQ, PNC13, TDAP
Symptoms: Bone pain, Cough, Fibromyalgia, Impaired work ability, Myalgia
Clinical narrative: Complaints of multiple muscular bone pain and nerve pain. "Flared up fibromyalgia" "couldn't work because of the pain". Now getting a cough. No trouble breathing, no swelling of sites or redness of sites.
Age: 52.0
Sex: M
Vaccine: HEP, HIBV, IPV, MNQ, PNC13, TDAP
Symptoms: Neuralgia
Clinical narrative: Complaints of multiple muscular bone pain and nerve pain. "Flared up fibromyalgia" "couldn't work because of the pain". Now getting a cough. No trouble breathing, no swelling of sites or redness of sites.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-year-old patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 02-NOV-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # N017686 with expiration date on 02-FEB-2020 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 27.4 degrees Fahrenheit for 4 hours and 30 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1712USA003239: US-009507513-1712USA003240.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator and refers to a 4 month old patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 30-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, (dose, frequency and route of administration were not reported) lot # M044397 with expiration date: 20-JUN-2018 or lot# N003984 with expiration date: 19-NOV-2018. The specific lot # of ROTATEQ administered to the patient was unknown by reporter. No adverse effects were reported. The ROTATEQ vaccine was stored in or above 32 degrees Fahrenheit (F) up to 35 F (35.4 F) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No causality assessment was provided by the reporter.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, 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 medical history, concurrent conditions and concomitant therapies were not reported. On 04-DEC-2017, the patient was inadvertently administered an expired dose of ROTATEQ orally, lot# M007307 and expiration date 30-NOV-2017 (dose was not reported). There were no adverse effects reported.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 18-year-old patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 09-NOV-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # N017686 with expiration date on 02-FEB-2020 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 27.4 degrees Fahrenheit for 4 hours and 30 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1711USA007294: US-009507513-1712USA003240.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-year-old patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 15-NOV-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # N017686 with expiration date on 02-FEB-2020 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 27.4 degrees Fahrenheit for 4 hours and 30 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1711USA007294: US-009507513-1712USA003239.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 25-Oct-2017 and additional information received on the same date. This case involves 65-year-old female patient who was vaccinated with FLUZONE HIGH-DOSE once (batch number: UI892AB, expiry date: 06-JUN-2018), intramuscularly in left deltoid (dose and dose in series was not reported) on 23-Oct-2017 in the evening. Patient's medical history and concomitant medications were not reported. On 24-Oct-2017, one day following the vaccination, patient noticed slight pink area. On 25-Oct-2017, two days post vaccination, the area from where she received the injection and below it was red. Patient noticed erythema extending down arm almost to elbow; redness was traveling down her arm. There was pain upon palpation and patient indicated that when she touches there area, there was some pain. Lab data and corrective treatment were not reported. The outcome of the event was reported as unknown at the time of reporting. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Laceration, Syringe issue
Clinical narrative: Initial unsolicited report received from office staff on 31 October 2017. This case involves a female patient (age was not reported) while administering the dose of ADACEL cuts her finger on an unspecified date. It was reported that she went to push in the plunger the glass rim broke and she cut her finger. She stated that she had not dropped the syringe prior to giving the vaccine. It was a case of syringe issue. Corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Initial unsolicited report received from a consumer (Case Coordinator) on 31-Oct-2017. This case involves a 81 year old female patient vaccinated with FLUZONE HIGH-DOSE (batch number, expiry date, dose in series, route, site were not reported) on an unknown date. Patient medical history not reported. It was also reported that patient had no known drug allergy and chronic illness. Concomitant medications were not reported. On 26 Sep 2017, unspecified time post vaccination, the patient experienced breaking out in a very itchy rash on the left torso. Lab data and corrective treatment were not reported. At the time of this report the event was ongoing. List of documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Blood aluminium increased, Diarrhoea, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 13-Nov-2017. This case involves a 28-year-old female patient who was vaccinated with a 0.5 ml single dose of TYPHIM VI (batch number: PE0653-1, expiration date, dose in series and site of administration were not reported) intramuscularly on 23-Aug-2010 prior to traveling. The patient's medical history and concomitant medications were not reported. It was also reported that the patient denied that she took oral tablets with the vaccine. On an unknown date, within a few days following the vaccination, the patient developed fever, diarrhea and gastrointestinal (GI) upset. Later, she had medical problems and on an unknown date, after the vaccination, she was diagnosed with an elevated aluminum level and she was wondering if it's related to this incident. Laboratory investigations and corrective treatment were not reported. On an unknown date, the patient recovered from fever, diarrhea and GI upset and the outcome of elevated aluminum level was not reported. Documents held by sender: none.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Initial unsolicited report received from consumer (Patients daughter) on 21 Nov 2017 and live follow up received on 21 Nov 2017. This case involves 93 years old female patient who was vaccinated with 0.5 ml dose of FLUZONE HIGH-DOSE (Form: injection, frequency: once, batch number: unknown, expiry date and site of administration were not reported) intramuscularly on 23 Oct 2017. No other vaccines at that time. Denies illness at the time of vaccination. Mom had history of hypersensitivity to eggs but she was always able to tolerate small doses. They are not sure whether mom took vaccine and then got into some additional egg products or it if was just something else in the vaccine that did it. Concomitant medication was not reported. On around 30 Oct 2017, seven days post vaccination, patient began with rash on feet which then progressed all the way up her body to her neck (broke out in "hive like rash" all over her body) and appeared to be hive like, patient states it does itch. Mom still has rash. Laboratory investigation was not reported. Doctor was called and recommended treatment with BENADRYL and steroid cream as needed. Patient was using clobetasol cream topically to control it. Patient was recovering from events. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from pharmacist on 22 Nov 2017. This case involves a female patient who is in her early 60s and was vaccinated with 0.5 ml dose of FLUZONE QIV (Frequency: once, batch number, expiry date and site of administration were not reported) intramuscularly on an unspecified date. The patient was undergoing chemotherapy. Concomitant medication was not reported. On an unspecified date, post vaccination, within 3 weeks she was admitted to the hospital with an active case of Influenza. Patient had to be hospitalized due to the severity of her symptoms. Other hospitalization details were not provided. Laboratory investigation and corrective treatment were not reported. Patient was recovering from event. List of documents held by sender: none. Sender's Comments: The patient experienced influenza post vaccination with FLUZONE QIV. Time to onset was compatible i.e. within three weeks but exact latency was not known. Patient was undergoing chemotherapy for an undisclosed condition. there was no information reported regarding the strain of influenza There could be an alternate etiology responsible for the event. Additional information regarding lap tests including PCR/serology should be obtained along with patients medical history, ongoing medical condition and status of immunity. Based upon reported information the role fo the vaccine can not be assessed.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Patient reported swollen arm, redness, pain when moving arm, and warm to touch. Patient went to ER due to the extreme swelling and tenderness of the arm.
Age: 85.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypotension, Influenza, Influenza A virus test positive
Clinical narrative: My mother had the vaccine and now has Influenza A and is fighting for her life in the hospital. She was a fully active person. She is a mess now! Her blood pressure, which was always high..she is on meds, is now VERY low. Today is day 4 in the hospital, with no sign of being released.
Age: 85.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Atrial fibrillation, Dehydration, Viral infection
Clinical narrative: My mother had the vaccine and now has Influenza A and is fighting for her life in the hospital. She was a fully active person. She is a mess now! Her blood pressure, which was always high..she is on meds, is now VERY low. Today is day 4 in the hospital, with no sign of being released.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Flushing, Nausea, Pain, Vomiting
Clinical narrative: Focused Assessment: Presents alone as referral from Occupational Health for further eval. Patient had flu vaccine yesterday and one hour later developed nausea with vomiting. Currently has flushed face, body aches, and nausea.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Hypoaesthesia oral, Nausea
Clinical narrative: LIP NUMPNESS, STOMACH CRAMPING, DIARRHEA, NAUSEA.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Muscle swelling
Clinical narrative: Patient had PREVNAR 13 1 year ago with no reaction. Came back after year to get PNEUMOVAX 23. Came back to pharmacy 2 days later left arm from deltoid muscle area all the way past elbow was red and swollen. Patient was advised by her doctor's office to take benadryl and if not better after 24 hours to seek treatment.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse referring to 8 unspecified patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-NOV-2017,  08-NOV-2017, 09-NOV-2017 and 10-NOV-2017, the patients were vaccinated with improperly stored VARIVAX lot # M046924 and expiration date on 28-NOV-2018 (dose and route of administration were not reported) for prophylaxis; which was reconstituted with sterile diluent (MRK) lot # N001534 and expiry date on 30-JUL-2019. The doses of VARIVAX were exposed to a temperature excursion of 19 degrees Fahrenheit (°F) during a time frame of 2 hours 20 minutes, which was detected by the data logger. Previous temperature excursion was reported as 17.1°F for 2 hours 10 minutes and 6.4 °F for 25 minutes. No adverse events were reported. Follow up information has been received from the nurse on 16-NOV-2017. The reporter stated that on unspecified dates an unspecified number of patients were inadvertently vaccinated with improperly stored VARIVAX lot # M046924 and expiration date on 28-NOV-2018 (dose and route of administration were not reported) for prophylaxis; which was reconstituted with sterile diluent (MRK) (lot # and expiration date unknown). The doses of VARIVAX were exposed to a temperature excursion of 6 degrees °F to 14 degrees °F during a time frame of 1 hours 20 minutes and 15 °F to 46 °F for 20 minutes which was not detected by the data logger. There was a previous temperature excursions reported as 6 °F to 14 °F for 12 hours and 30 minutes; and 15 °F to 46 °F for 1 hour and 30 minutes. No adverse events were reported.
Sex: F
Vaccine: MEN
Symptoms: Eye swelling, Lip swelling, Skin test negative, Urticaria
Clinical narrative: This is a literature report. Two serogroup B meningococcal (MenB) vaccines, MenB-FHbp and MenB-4C, are available for use in persons aged 10-25 years. The Advisory Committee on Immunization Practices (ACIP) recommends either three-dose series of MenB-FHbp or two-dose series of MenB-4C. Adverse reactions like anaphylaxis have been infrequently reported. With the relatively new development of the MenB vaccines, IgE-and non-IgE-mediated reactions have not been well documented in the literature. A case of delayed reaction to MenB-FHbp was reported. A 17-year-old female with Hashimoto's disease was evaluated for MenB-FHbp reaction. Six days after vaccination, she developed hives on the arms, torso and face with lip and periorbital swelling. She denied new medications, foods, other culprits or personal history of urticaria and angioedema. Patient required ER visit where she was treated with intravenous corticosteroid and diphenhydramine, with improvement. Subsequently, MenB-4C skin prick testing was performed with full strength of vaccine and intradermal to 1:100 concentration with negative results. She tolerated MenB-4C administered as a challenge without a reaction. Adverse reactions reported for the MenB-4C and MenB-FHbp include anaphylaxis in 0.13/1000 and 4/9,808 vaccines respectively. As the ACIP recommends the use of two-dose series minimum for either MenB vaccines and as more individuals are vaccinated, the knowledge of cross-sensitivity and management of allergic reactions to these vaccines is important. One of the first cases of delayed urticarial reaction with angioedema to MenB-FHbp vaccine was presented with subsequent safe administration of MenB4-C vaccination. Pfizer is marketing authorization holder of meningococcal Group B Rlp2086 in the reporter's country. This may be a duplicate report if another marketing authorization holder of meningococcal Group B Rlp2086 has submitted the same report to the regulatory authorities.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Swelling
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck (Case Number: 00668915) from a contactable consumer reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13 on an unknown date in 2015 at single dose for immunisation. The patient medical history and concomitant medications were not reported.   The patient experienced swelling and injection site pain on an unspecified date after receiving the vaccine injection with outcome of unknown. No further AE information to report. This information has not been reported to the FDA. No follow-up attempts are possible. No further information is expected.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, PPV
Symptoms: Crying, Emotional distress, Erythema, Irritability, Opisthotonus
Clinical narrative: Over 3 hours of extreme crying, arching back, and puking. Unable to calm down. Face turning extremely red. Swollen leg. Started at 6 pm and lasted until 9 pm. Next day she was very fussy as well. I called the doctor and they wont do anything for her.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, PPV
Symptoms: Peripheral swelling, Vomiting
Clinical narrative: Over 3 hours of extreme crying, arching back, and puking. Unable to calm down. Face turning extremely red. Swollen leg. Started at 6 pm and lasted until 9 pm. Next day she was very fussy as well. I called the doctor and they wont do anything for her.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Pyrexia
Clinical narrative: Pt has hx of recent flu shot 3 weeks ago. Has erythema and edema to right deltoid around injection site. Pt has hx of flu shot every year x 8 without difficulty or irritation at injection site. Pt states shot did not hurt at time of vaccination. No abnormal pain at time of injection. Pt states she noted each day since injection mild itching, mild fever, increasing daily around injection site.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Hypoaesthesia, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: Patient was given the flu vaccine by my colleague, on 10/22/17. She noticed a lot of pressure but not painful when receiving the vaccine. She started to experience pain around bedtime and was having difficulty moving her arm. This intense pain lasted for approximately 3 days and then her arm began to get better. Since then, she has had several episodes where she experiences pain and there are times where she needs assistance in getting dressed because she could not move her arm but they are intermittent. Her symptoms seem to be improving and the last time she had the paralysis/numbness was last week (around Dec 1st). The patient stated that the pain seems manageable with ibuprofen but does not want to continue taking it long term.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Paralysis
Clinical narrative: Patient was given the flu vaccine by my colleague, on 10/22/17. She noticed a lot of pressure but not painful when receiving the vaccine. She started to experience pain around bedtime and was having difficulty moving her arm. This intense pain lasted for approximately 3 days and then her arm began to get better. Since then, she has had several episodes where she experiences pain and there are times where she needs assistance in getting dressed because she could not move her arm but they are intermittent. Her symptoms seem to be improving and the last time she had the paralysis/numbness was last week (around Dec 1st). The patient stated that the pain seems manageable with ibuprofen but does not want to continue taking it long term.
Age: 75.0
Sex: M
Vaccine: UNK
Symptoms: Vertigo
Clinical narrative: Vertigo.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Patient SAID HE IS NOW HAVING PAINS AROUND UPPER LEFT SHOULDER. THINKS IT MAY BE FROM FLU SHOT GIVEN ABOUT A MONTH AGO.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site inflammation, Injection site swelling
Clinical narrative: Site for the injection was swollen, inflamed and very hard per patient the night of vaccine day. Upon inspection by me the next day the local site was extremely hard , swollen and inflamed above regular.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hypotonic-hyporesponsive episode, Pyrexia
Clinical narrative: Hyporesponsive hypotonic event. 102 degree fever, taken by EMS to hospital, transferred to another hospital. No tonic clonic movement.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site induration, Injection site reaction, Urticaria
Clinical narrative: Upon giving the vaccine the pt bleed some but then a raised welt appeard that was hard to the touch. The pt did not complain of any pain or signs of an allergic reaction. However the raised pimple like bump appeared very quickly. He had no pain to his arm and had no problems with range of motion. As the patient waited the necessary 15 minutes for a allergic reaction the welt did diminsh slightly. However because of the time frame of the reaction I sent the pt to urgent care to ensure it is not an allergic reaction.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Patient developed a rash that was bright red, hot, itchy, and mildly erythematous and approximately 10 cm long and 5 cm wide. This was treated for approximately 24 hours with an oral antihistamine x 3 doses and ibuprofen x 3 doses. The rash did not full resolve for approximately 72 hours.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received flu shot Thurs afternoon and by Friday there was a bright red patch covering 75% of outer arm starting about an inch below injection site. By Saturday pm the entire upper arm was swollen, red, and warm down to the elbow. We outlined in Sharpie. By Sunday am it had spread outside the marking so brought him to Urgent Care and was prescribed antibiotic for cellulitis.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported chills and slight pain at injection site on 12/4/17 and then next day had signs and symptoms of skin infection on arm but not at injection site. Arm was red, warm, tender, swollen on inside of right arm above elbow and around bicep.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin infection
Clinical narrative: Patient reported chills and slight pain at injection site on 12/4/17 and then next day had signs and symptoms of skin infection on arm but not at injection site. Arm was red, warm, tender, swollen on inside of right arm above elbow and around bicep.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Contusion, Discomfort, Haemorrhage, Pain
Clinical narrative: Patient reports bleeding once the vaccine given, and now a bruise (dark blue in color) about the size of a 50 cent piece has appeared on her arm. Patient reports slight pain, weakness, discomfort.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient developed redness, swelling, warmth, pain, and itching at the site of the injection, this occurred approximately 48 hours after receiving the vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist, regarding a female patient of unknown age. The patient's medical history and historical or current medications were unknown by the reporter and she had no listed drug reactions or allergies. On 07-NOV-2017 the patient was administered a dose of ZOSTAVAX (reported as 19400 PFU) for prophylaxis, with product lot # N023328 and expiration date 22-NOV-2018. The dose, route of administration and anatomical location were not provided. As other suspect therapy it was reported the sterile diluent used to reconstitute ZOSTAVAX, which dose, route of administration, lot # and expiration date were unknown. After the vaccination, the patient developed localized itching, redness, heat and circular marks around the injection site. It was unknown by the reporter if the patient received treatment or sought medical attention for the events. The pharmacist also reported that both ZOSTAVAX and sterile diluent did not undergo a temperature excursion. The recovery status of the patient by the time of the reporting and the association between the suspect products and the event were unknown.
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer communicated to a Pfizer colleague, reporting for the consumer himself. This male patient of an unspecified age received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient had shoulder pain after receiving the vaccine for at least four weeks on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected. No follow-up attempts are possible, information about lot number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Immediate post-injection reaction, Pain
Clinical narrative: I gave the PNEUMOVAX vaccine first and he said he felt nothing but when I gave the FLUZONE HD he said he felt it immediately and he came back a couple days later because it was so red and painful. The redness and pain lasted about a week and he described the pain as being very bad but he didn't want to go to a doctor. It got better without.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Eye swelling, Lip swelling, Nasal congestion, Sneezing
Clinical narrative: Within less than 5 minutes of receiving 4 yr vaccines listed above child developed sneezing, large urticaria over entire body, nasal congestion lip and eye swelling. Resp 28 AP120 At 3:45pm first dose of Benadryl given 12.5mg/5ml gave 7.5ml by mouth. 3:52pm Epi 0.18ml given IM Resp 24 AP 140 @3:55pm 02 Sat at 92% before epi given 96% after epi Had some coughing but never in respiratory distress. Respirations were regular and unlabored throughout. 1600 patient was transported via ambulance with his mom to Hospital.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Within less than 5 minutes of receiving 4 yr vaccines listed above child developed sneezing, large urticaria over entire body, nasal congestion lip and eye swelling. Resp 28 AP120 At 3:45pm first dose of Benadryl given 12.5mg/5ml gave 7.5ml by mouth. 3:52pm Epi 0.18ml given IM Resp 24 AP 140 @3:55pm 02 Sat at 92% before epi given 96% after epi Had some coughing but never in respiratory distress. Respirations were regular and unlabored throughout. 1600 patient was transported via ambulance with his mom to Hospital.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site indentation
Clinical narrative: Reports that she has an indention on her left deltoid area. She believes it was from when she received the influenza immunization.  She denies any muscular issues or ROM deficiencies. She just wants to document. The indention measures 1 X 1.5 cm. No discoloration or bruising noted to the area. Verified per clinic immunization received in left deltoid on 10/27.
Age: 1.83
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood alkaline phosphatase increased
Clinical narrative: Patient had abnormally high Alkaline Phosphatase levels after receiving flu vaccine. Alkaline Phosphatase level was 5129 on 11/17/2017 and 3704 on 12/1/2017 (reference range for Alkaline Phosphatase is 130-317 IU/L).
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Reported decreased range of motion to left arm/shoulder, aching pain, swelling, inability to lift arm for few days. Took ibuprofen for pain and swelling with minimal relief.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Wrong drug administered
Clinical narrative: Hib vaccine accidently given.
Age: 51.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient's left arm was red, swollen, and warm to the touch from the shoulder down to his elbow. Arm was very painful and difficult to lift. Did get better on its own after several days.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Painful to touch which persisted for 7 days after the shot. During the next 3 weeks, the patient did not notice any pain and thought it had disappeared. She reports a "similar" pain that came about on the date reported. She cannot locate the exact spot of the pain but states its in the same area as the shot. She does not recall doing any activity which cause pain.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Patient describes a large red, inflamed, painful area approximately the size of his hand around the injection site. Patient is taking ibuprofen/TYLENOL.
Sex: U
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Clinic provider claims they have seen adverse events from FLUZONE HIGH DOSE vaccine given at other facilities.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Not pregnant. Pinkish area about the size of her hand on her L deltoid area that she just noticed Wed evening. Feels warms to the touch but does not limit her range of motion. Pain scale of 3/10 that she notices more when she goes to move it. No fever present.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Scab
Clinical narrative: Rash on face and trunk with scabbing of some lesions. No itching, no fever. Have continued to break out over past few days.
Age: 47.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: The patient received the flu vaccine on 12/1/17 around 14:00, later that evening he noticed pain to the left arm/shoulder. The pain became more noticeable on Saturday evening. No redness or swelling to the site, shoulder, or armpit region. The patient reports achiness and stiffness to the left shoulder. He reports being able to raise his arm above his head but experiences some limited range of motion with certain movements. Denies fever, chills, or feeling ill.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Pyrexia, Rash, Rash erythematous, Skin warm
Clinical narrative: Pt presented to the pharmacy on Wednesday afternoon after receiving a PNEUMOVAX 23 on Monday. He had a red rash on the lower part of the upper arm. It was warm to touch. He also had a small rash on the upper trunk. He reported running a fever of up to 101F the night before.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient stated that she had redness and swelling at the injection site and that it also felt hard. She stated that after approximately two weeks she developed a rash on her face and around her eye.  She said that she was seen at a local Urgent Treatment center where she was told that she had shingles and received a Toradol injection and  scripts for acyclovir and a prednisone pack. She said that she was also seen at Optical store where she was given a sample of a wetting drops to prevent dry eye. She also said that she had a constant headache which finally went away today December 6, 2017. She came in today to pick up a refill for another rx and that is when she told me about her reaction to the vaccination.