chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and ethnicity. No information was provided regarding the patients' previous drug reactions, allergies, concurrent conditions, concomitant medications or medical history. On an unknown date, the patients' were vaccinated with improperly stored doses of GARDASIL 9 (lot# R009615 and expiration date of 07-DEC-2020; (dose, frequency, anatomical location and route of administration were not reported) for prophylaxis.  Nonetheless, no adverse effects were reported.  The vaccine experienced the following temperature excursion on an unknown date: 32degrees Fahrenheit (F) up to 35 F (31.5 F) during a time frame for 5 minutes. Reportedly, there had been a previous temperature excursions of  32 F up to 35 F (33 F) for 10 minutes the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis, Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated (date not reported) with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed a painful rash appearing on his lower back, legs, arms, chests (as reported) and head. In response to these complaints, the patient presented to a physician (date not reported) and was diagnosed as suffering from dermatitis, shingles, and post herpetic neuralgia. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-SEP-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed a painful rash appearing initially on his mid-torso, and radiating thereafter onto his upper and lower back. In response to these complaints, on or about 03-OCT-2016, the patient presented to a physician and was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-OCT-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed a painful rash appearing on his left upper thigh and hip. In response to these complaints, on or about 14-OCT-2016, the patient presented to a physician and was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX.  The outcome of the events is unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (the dosage regimen information was not reported) lot # R012531 (expiration date: 01-MAY-2020) for prophylaxis, reconstituted with properly stored sterile diluent. No adverse effects were reported. The VARIVAX vaccine was exposed to a temperature excursion of 15-46 Celsius degrees (19.9 Fahrenheit degrees) for 21 hours and 32 minutes. There were no previous excursions and it was found because of a digital data logger.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician and refers to a female patient of unknown age. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 11-SEP-2018, the patient was vaccinated with Oka/Merck VARIVAX lot # N035940 and expiration date 18-DEC-2019; and M-M-R II (lot# and expiration date unknown) both vaccines for prophylaxis (dose, strength, and route of administrations were unknown). It was reported that the patient was later found to be pregnant at the time of administration (maternal exposure during pregnancy), no adverse effects were reported. Last menstrual period, conception date, and estimated date of delivery were unknown. Outcome for maternal exposure during pregnancy was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Cervical dysplasia, Human papilloma virus test positive
Clinical narrative: This spontaneous report was received from a Physician via a company representative referring to a 26 year old female patient. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL 9 (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. The physician reported that a "lack of efficacy" took place on an unspecified date. It was also reported that the patient was diagnosed with advance cervical dysplasia and was also Human Papillomavirus (HPV) positive. Therefore, the patient sought medical attention and was seen by the physician. At the reporting time the outcome of the adverse events was unknown. The causality assessment between the adverse events and therapy with GARDASIL 9 was not reported.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Neck pain, Pyrexia
Clinical narrative: This case was reported by a nurse via out of hour services and described the occurrence of fatigue in a 53-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 21st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue, fever, injection site pain, myalgia and neck pain. On an unknown date, the outcome of the fatigue, fever and myalgia were recovered/resolved and the outcome of the injection site pain and neck pain were not recovered/not resolved. It was unknown if the reporter considered the fatigue, fever, injection site pain, myalgia and neck pain to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to the manufacturer. The patient received a dose of SHINGRIX in left deltoid. Caller is a nurse practitioner. The patient stated that after receiving a dose of SHINGRIX, she experienced fatigue, myalgia, low grade fever and soreness at the injection site. The patient stated that the symptoms lasted approximately a couple of days. However, the soreness at the injection site lasted approximately 1 week and turned into neck pain. This case was link to case US2018146850, reported by the same reporter for the same patient.
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported for her mother via Pfizer sales representative. An elderly (over 65 years) female patient 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 experienced redness up arm on an unspecified date with outcome of unknown. The information on the lot number has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUX, MMRV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old male patient who received expired dose of vaccine received vaccine DAPTACEL lot C5041BA, expiry date: 02-Sep-2018, unknown route in the right deltoid On 01-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (INFLUENZA) for Immunization; (ENDERS-EDMONSTON), (JERYL LYNN), (OKA/MERCK) PROQUAD for Immunization; and HEPATITIS A for Immunization. It was a case of actual medication error due to expired vaccine used. No known symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 62 years old female patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication received. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ000AB (expiry date: 28-Mar-2019) via unknown route in the left deltoid. It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose. No adverse reaction occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error..
Age: 12.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA278726, 2018SA278737 and 2018SA278731 (same reporter). This case involves a 12 years old male patient who was vaccinated with a dose of IPV (VERO) (lot P1A171M and expiration date 20-APR-2024) via unknown route in the left deltoid on 25-Sep-2018 which was stored incorrectly. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was reported that vaccine was exposed to temp. Elevated for 3 days to 46.6 F & 48 F. No information reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Initial unsolicited report received from pharmacist on 02-Oct-2018. This case involves a 73 years old female patient who was vaccinated with a 0.5 ml dose of FLUBLOK QIV (Batch number: QFAA1810, expiration date: 30-Jun-2019, site of administration: right deltoid and route was not reported) on 25-Sep-2018 and 01-Oct-2018. The patient's concomitant medications included SHINGRIX. The patient's medical history were not reported. It was an actual medication error due to Extra dose administered (received FLUBLOK last week and again yesterday). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA277148, 2018SA278731 and 2018SA278737. This case involves 17 years male patient who received vaccine IPOL lot number not reported via unknown route in the left deltoid (expiry date and dose not reported) on 28-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that stability of IPOL after the temperature elevated for 3 days to 46.6 Fahrenheit and 48 Fahrenheit. The caller reports that 4 IPOL vaccines were given. It was reported that no reactions were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Loss of consciousness, Syncope, Wheezing
Clinical narrative: 3 minutes after received vaccine, wheezing was reported and she passed out. Would not come to despite lowering to floor, lifting legs, stimulation. EPI-PEN given, she immediately woke up. Transferred to ED, Did EKG's which were (-). Diagnosed with syncope episode.
Age: 44.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Dyspnoea, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: 10/5/18 Pt. had office visit for upcoming surgery- Influenza and Pneumococcal 23 given 10/6/18- Pt. to ER for SOB, arm red swollen and fever. 10/8/18- Pt. OV for re-eval of reaction.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother of patient called on 10/09/18 and reported that on 10/06/18 child's left upper arm became very red, warm and swollen and she had a temperature of 100. Mother informed that she gave the child TYLENOL, BENADRYL and a cool compress was placed at the site. It was reported that on 10/08/18 the patient's upper arm became less warm and red and had a bluish tint ("almost like a bruise"). The Mother said on 10/09/18 that the area looked much better and there were no more side effects. Mother further stated that the patient had had the influenza vaccine for the past 3 years and she has never had any kind of side effect or reaction.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Extreme pain and when moving the left shoulder for several weeks with no sign of getting better.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient called on 10/04/18 and said started feeling "really bad" and the area that she got her shot became red, swollen and warm. She said her temperature was 103 for 2 days. Patient reported that she took TYLENOL, BENADRYL and used a cool compress on her arm. She started feeling better on 10/06/18. No further problems per patient.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Swelling.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Angioedema, Pharyngeal oedema, Pruritus
Clinical narrative: Throat swelling, angioedema, itchy.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: No adverse event
Clinical narrative: No adverse reactions observed.
Age: 0.58
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 7 month old female patient. The patient's medical history was not reported. On 25-SEP-2018, the 7 month old patient was vaccinated with a dose of VAQTA lot # R013858, expiration date 12-JUN-2019, intramuscular for prophylaxis. No adverse effect was reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Arthralgia, Disturbance in attention, Dizziness, Fatigue, General symptom
Clinical narrative: This spontaneous report was received from a physician via social media refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL and GARDASIL 9 (lot# and expiry date unknown) for prophylaxis. On an unknown date, the patient experienced illness (ill-defined disorder), chronic condition (general symptom), poor concentration (disturbance in attention), adverse event (unspecified), extreme tiredness (fatigue), dizziness, pain in joint (arthralgia) and pain in muscle (myalgia). The patient was hospitalized due to unspecified adverse event. The outcome of all the events was unknown. The causality assessment was not reported. The reporter considered unspecified adverse event as life threatening.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Ill-defined disorder, Myalgia
Clinical narrative: This spontaneous report was received from a physician via social media refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL and GARDASIL 9 (lot# and expiry date unknown) for prophylaxis. On an unknown date, the patient experienced illness (ill-defined disorder), chronic condition (general symptom), poor concentration (disturbance in attention), adverse event (unspecified), extreme tiredness (fatigue), dizziness, pain in joint (arthralgia) and pain in muscle (myalgia). The patient was hospitalized due to unspecified adverse event. The outcome of all the events was unknown. The causality assessment was not reported. The reporter considered unspecified adverse event as life threatening.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 02-JUL-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 15-APR-2016, the patient was treated by a nurse practitioner for the onset of a vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Erythema, Pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received PREVNAR 13 (lot number and expiration date not provided) and influenza vaccine both via unspecified routes of administration on unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness and pain below the application site on an unspecified date. Outcome of the events was unknown. Information on lot/batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had rash at injection site. The outcome of the event was unknown. Information on the lot number has been requested.
Age: 60.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Fatigue, Loss of personal independence in daily activities, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever of 101 for 30 hours, muscle aches, exhaustion, unable to go to work, nausea continuing into 48 hours.
Age: 74.0
Sex: F
Vaccine: FLUR4, PNC13
Symptoms: Erythema, Injection site erythema, Injection site pain, Pruritus
Clinical narrative: Patient was administered PREVNAR-13 in the right arm on 10/02/2018, and FLUBLOK QUADRIVALENT in the left arm on 10/02/2018. Patient said that the PREVNAR-13 injections site was sore the day of vaccination and went away on 10/04/2018. Patient said that her arm started to become red on 10/04/18 and the redness spread and itch. Patient she put alcohol and ice on the red area. Patient said her right arm was red on the upper arm only around the injection site.  Patient went to Priamary care physician on 10/09/208. Dr. told patient to start taking BENADRYL.  Patient took first dose of BENADRYL 25 mg at 12:00 pm on 10/10/2018 and second of BENADRYL 25 mg at 4:00 am on 10/10/2018 third dose of BENADRYL 25 mg was taken at 10:00 am 10/10/2018. Patient reports redness is improving no longer itching and will be following up with Dr. on 10/11/2018.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Somnolence
Clinical narrative: Extreme fatigue greater than 24 hours, sleepiness greater than 24 hours, soreness at injection site.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Head injury, Loss of consciousness, Pallor, Skin warm
Clinical narrative: Patient received injection then after one min. Patient had Band-Aid applied then walked out to pick out a sucker and went out to lobby with her dad to wait on school excuse and passed out falling forward hitting head on table. Color pale and skin cool and moist aroused in approx. 15 sec. Tearful. PERLA. Moving all extremities. Exam done by FNP (feels patient vasovagal, family history of vasovagal by older brother). 0942am skin warm and dry vs 114/78 t 97.9. P94, r22, spo2 100% ra no n/v no dizziness. No c/o.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Tearfulness
Clinical narrative: Patient received injection then after one min. Patient had Band-Aid applied then walked out to pick out a sucker and went out to lobby with her dad to wait on school excuse and passed out falling forward hitting head on table. Color pale and skin cool and moist aroused in approx. 15 sec. Tearful. PERLA. Moving all extremities. Exam done by FNP (feels patient vasovagal, family history of vasovagal by older brother). 0942am skin warm and dry vs 114/78 t 97.9. P94, r22, spo2 100% ra no n/v no dizziness. No c/o.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Haemorrhage, Swelling
Clinical narrative: Patient experienced swelling and bleeding. Applied a cold pack per protocol and advised to follow up if condition worsened.
Age: 82.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt exhibited swelling, redness and pain at injection site. Possible infection. Still persistent after 5 days. Pt was counseled to monitor recovery and to seek medical attention if symptoms did not improve or worsened.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Minimal swelling of left lower neck/clavicle region. States this happened to her in the past after Td administration. No redness, no erythema noted.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, soreness at site of injection reported.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient complained of burning, itching, and redness around the injection site area that lasted for the course of about 1 week. Patient states that this occurred one day after the injection was administered.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Enlarged uvula, Fatigue, Injection site swelling, Throat irritation
Clinical narrative: Employee describes her bicep "blowing up" (i.e. being swollen) post vaccination. Denies deltoid swelling. During her shift, she started feeling run down; went home to sleep. When she woke up, reports feeling her throat "felt odd." Her voice was hoarse and her uvula was visibly swollen. When she returned to work for her scheduled shift, her co-workers confirmed visual swelling. She sipped ice water all day and swelling never advanced. No c/o respiratory issues. No medical intervention.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, Redness and warmth of injection site.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site red, swollen and itching.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: During the night I had headache, sore arm, mild nausea. General discomfort. Took a TYLENOL at 600 AM. Symptoms lessened. Generally tired during the day. By 6PM I was back to normal.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness, warmth, swelling surrounding vac. site.
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthma, Condition aggravated, Fatigue
Clinical narrative: Pt stated that she went home and was watching TV when she had an asthma attack (which responded well to Albuterol) and then she was very VERY tired, and slept for hours and hours extra that night/following morning. She came in to tell me about it and said she felt fine then. She states having had a flu shot every year and this year was the first time something happened- "must be really strong this year".
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Rash vesicular
Clinical narrative: Blister like rash on left lower extremity.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness, warmth, swelling, soreness around vac site.
Age: 14.0
Sex: F
Vaccine: FLUR4
Symptoms: Wrong product administered
Clinical narrative: None-Error inappropriate vaccine administered for age of pt.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Joint range of motion decreased, Mobility decreased, Pain
Clinical narrative: Patient reports that she felt a deep ache within an hour of the PPSV23 injection. The next day her arm was immobile, and movements were more painful. On Friday, there was more soreness than expected. She took a couple of tylenol and a couple of Advil, but nothing helped. Started ibuprofen and alternating ice/heat on Saturday. She was able to start moving her arm better on Monday, and today it is significantly better, but still experiencing aching and does not yet have full ROM.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: Baby began vomiting approximately an hour after receiving vaccines.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Left upper arm around the site where injected is covered in a red rash, hot to touch, and very sore.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Chest X-ray normal, Febrile convulsion, Nasal congestion, Pyrexia
Clinical narrative: Patient had a fever and related seizure about 12 hours after having his 1 year old vaccinations.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This social media spontaneous report was received from a consumer, who made a post on 08-SEP-2018 that included a video. The title of the video was "manufactured crisis - HPV , hype and horror", in which a reporter mentioned information about an unspecified number of female patients of unknown age. The patients' medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, the patients were vaccinated with GARDASIL for prophylaxis (strength, dose, frequency, route, anatomical location, lot # and expiration date were not provided). On an unspecified date, unspecified patients were going to have menopause (premature menopause) and infertility. (It was stated that those patients had  16 years old). Also, an unspecified number of patients experienced fatigue, could not breath, presented asthma, fell on the ground (fall),  experienced a seizure, loss of consciousness, depression, anxiety, had an ovarian dysfunction (ovarian disorder) and  presented a miscarriage. On an unspecified date, an unspecified patients died. The cause of death was not provided and it was unknown if autopsy was performed or not.  At the reporting time, the outcome of loss of consciousness, fatigue, asthma, fall, infertility, anxiety, depression, ovarian disorder, dyspnoea, premature menopause, seizure and abortion spontaneous was not reported. The reporter did not assess the relatedness between GARDASIL and the aforementioned events. Upon internal review, the events seizure, abortion spontaneous and loss of consciousness were determined to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a medical assistant and refers to an adult patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 28-SEP-2018, the patient was vaccinated with a pediatric dose of VAQTA intramuscularly, (exact dose, frequency, lot # and expiration date were not reported). No known adverse effects were reported. No causality assessment was provided.
Sex: F
Vaccine: HPV9
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency, route and site of administration, lot# and expiration date were not reported) for prophylaxis (reported as FDA approved indication). On an unknown date the patient experienced postural orthostatic tachycardia syndrome. The outcome of the event was unknown. Causality assessment was not reported.
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Body temperature increased, Dizziness, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: This is a spontaneous report from a contactable nurse. A 17-year-old female patient received TRUMENBA (Lot Number: T52806, Expire Date: 01Dec2019, intramuscular at 0.5 ml, single in the right deltoid on 24Sep2018 08:30 and MENACTRA (Lot Number: U6016AA, Expiry Date: 09Oct2019, NDC number: 0005-01000-01), intramuscular at 0.5 ml, single in the left deltoid on 24Sep2018, both for immunisation. Medical history none. Concomitant medications were not reported. The patient previously took one dose of MENACTR on 12Jul2012 for immunisation. The patient experienced temperature of 102.1 degrees Fahrenheit on 24Sep2018 10:30 with outcome of unknown, body aches on 24Sep2018 10:30 with outcome of unknown, headache on 24Sep2018 10:30 with outcome of not recovered, dizziness on 25Sep2018 with outcome of not recovered, stiff neck on 24Sep2018 10:30 with outcome of not recovered, vomiting on 24Sep2018 10:30 with outcome of unknown. Reporter seriousness for these events was medically significant. On unknown date stiff neck had worsened with outcome of unknown. The events were described as follows: The nurse had a patient that possibly had an adverse reaction to the TRUMENBA. 2 hours after the injection, the patient had a temperature of 102.1 degrees Fahrenheit, body aches, headaches, stiff neck, and vomiting. These events started within 2 hours of receiving the injection on 24Sep2018. The patient came in the next day to the walk in clinic with these symptoms and was especially concerned about the stiff neck. The patient  also received Menactra on the same day. The patient also experienced dizziness that began one day later, on 25Sep2018. The nurse does not know if the patient still has these symptoms, or if she recovered. She knows that on 26Sep2018 the patient still had a headache, was a little dizzy, and still had some symptoms. The patient came in the next day to the walk in clinic to be seen for the symptoms. At that time, the stiff neck had worsened. The nurse denies other medical conditions and medical tests. She states that the patient was treated with Ondansetron for nausea and vomiting. She was also instructed to take Tylenol or Ibuprofen.; Sender's Comments: Based on the information currently available, a contributory role of TRUMENBA towards the occurrence of "fever, body aches, headache,  dizziness, stiff neck and vomit" cannot be fully excluded considering the close time association. 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 and Investigators, as appropriate.
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Pain, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse. A 17-year-old female patient received TRUMENBA (Lot Number: T52806, Expire Date: 01Dec2019, intramuscular at 0.5 ml, single in the right deltoid on 24Sep2018 08:30 and MENACTRA (Lot Number: U6016AA, Expiry Date: 09Oct2019, NDC number: 0005-01000-01), intramuscular at 0.5 ml, single in the left deltoid on 24Sep2018, both for immunisation. Medical history none. Concomitant medications were not reported. The patient previously took one dose of MENACTR on 12Jul2012 for immunisation. The patient experienced temperature of 102.1 degrees Fahrenheit on 24Sep2018 10:30 with outcome of unknown, body aches on 24Sep2018 10:30 with outcome of unknown, headache on 24Sep2018 10:30 with outcome of not recovered, dizziness on 25Sep2018 with outcome of not recovered, stiff neck on 24Sep2018 10:30 with outcome of not recovered, vomiting on 24Sep2018 10:30 with outcome of unknown. Reporter seriousness for these events was medically significant. On unknown date stiff neck had worsened with outcome of unknown. The events were described as follows: The nurse had a patient that possibly had an adverse reaction to the TRUMENBA. 2 hours after the injection, the patient had a temperature of 102.1 degrees Fahrenheit, body aches, headaches, stiff neck, and vomiting. These events started within 2 hours of receiving the injection on 24Sep2018. The patient came in the next day to the walk in clinic with these symptoms and was especially concerned about the stiff neck. The patient  also received Menactra on the same day. The patient also experienced dizziness that began one day later, on 25Sep2018. The nurse does not know if the patient still has these symptoms, or if she recovered. She knows that on 26Sep2018 the patient still had a headache, was a little dizzy, and still had some symptoms. The patient came in the next day to the walk in clinic to be seen for the symptoms. At that time, the stiff neck had worsened. The nurse denies other medical conditions and medical tests. She states that the patient was treated with Ondansetron for nausea and vomiting. She was also instructed to take Tylenol or Ibuprofen.; Sender's Comments: Based on the information currently available, a contributory role of TRUMENBA towards the occurrence of "fever, body aches, headache,  dizziness, stiff neck and vomit" cannot be fully excluded considering the close time association. 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 and Investigators, as appropriate.
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Dizziness, Headache, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse. A 17-year-old female patient received TRUMENBA (Lot Number: T52806, Expire Date: 01Dec2019, intramuscular at 0.5 ml, single in the right deltoid on 24Sep2018 08:30 and MENACTRA (Lot Number: U6016AA, Expiry Date: 09Oct2019, NDC number: 0005-01000-01), intramuscular at 0.5 ml, single in the left deltoid on 24Sep2018, both for immunisation. Medical history none. Concomitant medications were not reported. The patient previously took one dose of MENACTR on 12Jul2012 for immunisation. The patient experienced temperature of 102.1 degrees Fahrenheit on 24Sep2018 10:30 with outcome of unknown, body aches on 24Sep2018 10:30 with outcome of unknown, headache on 24Sep2018 10:30 with outcome of not recovered, dizziness on 25Sep2018 with outcome of not recovered, stiff neck on 24Sep2018 10:30 with outcome of not recovered, vomiting on 24Sep2018 10:30 with outcome of unknown. Reporter seriousness for these events was medically significant. On unknown date stiff neck had worsened with outcome of unknown. The events were described as follows: The nurse had a patient that possibly had an adverse reaction to the TRUMENBA. 2 hours after the injection, the patient had a temperature of 102.1 degrees Fahrenheit, body aches, headaches, stiff neck, and vomiting. These events started within 2 hours of receiving the injection on 24Sep2018. The patient came in the next day to the walk in clinic with these symptoms and was especially concerned about the stiff neck. The patient  also received Menactra on the same day. The patient also experienced dizziness that began one day later, on 25Sep2018. The nurse does not know if the patient still has these symptoms, or if she recovered. She knows that on 26Sep2018 the patient still had a headache, was a little dizzy, and still had some symptoms. The patient came in the next day to the walk in clinic to be seen for the symptoms. At that time, the stiff neck had worsened. The nurse denies other medical conditions and medical tests. She states that the patient was treated with Ondansetron for nausea and vomiting. She was also instructed to take Tylenol or Ibuprofen.; Sender's Comments: Based on the information currently available, a contributory role of TRUMENBA towards the occurrence of "fever, body aches, headache,  dizziness, stiff neck and vomit" cannot be fully excluded considering the close time association. 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 and Investigators, as appropriate.
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse. A 17-year-old female patient received TRUMENBA (Lot Number: T52806, Expire Date: 01Dec2019, intramuscular at 0.5 ml, single in the right deltoid on 24Sep2018 08:30 and MENACTRA (Lot Number: U6016AA, Expiry Date: 09Oct2019, NDC number: 0005-01000-01), intramuscular at 0.5 ml, single in the left deltoid on 24Sep2018, both for immunisation. Medical history none. Concomitant medications were not reported. The patient previously took one dose of MENACTR on 12Jul2012 for immunisation. The patient experienced temperature of 102.1 degrees Fahrenheit on 24Sep2018 10:30 with outcome of unknown, body aches on 24Sep2018 10:30 with outcome of unknown, headache on 24Sep2018 10:30 with outcome of not recovered, dizziness on 25Sep2018 with outcome of not recovered, stiff neck on 24Sep2018 10:30 with outcome of not recovered, vomiting on 24Sep2018 10:30 with outcome of unknown. Reporter seriousness for these events was medically significant. On unknown date stiff neck had worsened with outcome of unknown. The events were described as follows: The nurse had a patient that possibly had an adverse reaction to the TRUMENBA. 2 hours after the injection, the patient had a temperature of 102.1 degrees Fahrenheit, body aches, headaches, stiff neck, and vomiting. These events started within 2 hours of receiving the injection on 24Sep2018. The patient came in the next day to the walk in clinic with these symptoms and was especially concerned about the stiff neck. The patient  also received Menactra on the same day. The patient also experienced dizziness that began one day later, on 25Sep2018. The nurse does not know if the patient still has these symptoms, or if she recovered. She knows that on 26Sep2018 the patient still had a headache, was a little dizzy, and still had some symptoms. The patient came in the next day to the walk in clinic to be seen for the symptoms. At that time, the stiff neck had worsened. The nurse denies other medical conditions and medical tests. She states that the patient was treated with Ondansetron for nausea and vomiting. She was also instructed to take Tylenol or Ibuprofen.; Sender's Comments: Based on the information currently available, a contributory role of TRUMENBA towards the occurrence of "fever, body aches, headache,  dizziness, stiff neck and vomit" cannot be fully excluded considering the close time association. 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 and Investigators, as appropriate.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 18 months old male patient received vaccine QUADRACEL which was not intended to. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE for Immunization; and HEPATITIS A VACCINE for Immunization. On 01-Oct-2018, the patient received a Fourth dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5325BA expiry date: 14-Nov-2019 via intramuscular route in the left thigh. It was case of actual medical error due to inappropriate age at vaccine administration. It was not reported that if any adverse event was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.