chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: HCP did not report any side effects from  the administration of the PROQUAD; HCP stated that a 58 year old female patient was inadverntly administered the PROQUAD vaccine.; HCP stated that the" nurse was not paying attention and grabbed the wrong vaccine from the drawer; This spontaneous report was received from a Nurse and refers to a 58-year-old female patient.  The patient's medical history, vaccination history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 01-APR-2024, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W038810, expiration date: 04-JUN-2024, (strength, exact dose and route of administration were not provided) administered for prophylaxis (product administered to patient of inappropriate age). The reporter stated that "the nurse was not paying attention and grabbed the wrong vaccine from the drawer" (Wrong product administered) and the administration was due to a medication error on behalf of the nurse. Operator of device was reported as Health professional. The reporter did not report any side effects from the administration of the vaccine. No additional adverse event nor product quality complaint reported.
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient had received the 3rd dose of Engerix-B; patient had received the 2nd dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 43-year-old female patient who received HBV (Engerix B) (batch number 7MH25, expiry date 07-DEC-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (Patient received 1st dose on 19th July 2023).   On 28-MAR-2024, the patient received the 3rd dose of Engerix B. On 28-DEC-2023, the patient received the 2nd dose of Engerix B. On 28-DEC-2023, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: patient had received the 2nd dose of Engerix-B). On 28-MAR-2024, the patient experienced drug dose administration interval too long (Verbatim: patient had received the 3rd dose of Engerix-B). The outcome of the drug dose administration interval too long and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-APR-2024 The reporter reported that a patient had received the third dose of Engerix-B after the recommended interval, with the first one being in 19th July 2023, the second one in 28th December 2023 and the third one given on 28th March 2024 which led to drug dose administration interval too long. The adverse event was collected on the second phone call. The medical information was sent. The vaccine administration facility was the same as primary reporter. The reporter granted permission for consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Administration site cellulitis
Clinical narrative: Patient received first dose of Shingrix she got cellulits on site of administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 29Z52, expiry date 18-APR-2026) for prophylaxis.   On 12-APR-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site cellulitis (Verbatim: Patient received first dose of Shingrix she got cellulits on site of administration). The outcome of the injection site cellulitis was unknown.   It was unknown if the reporter considered the injection site cellulitis to be related to Shingrix.     It was unknown if the company considered the injection site cellulitis to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-APR-2024 The reporter called and stated that the patient received dose of Shingrix and got cellulits on site of administration. The reporter enquired should the patient take second dose.  The reporter stated she couldn't give any patient information because the company wont let her. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 49-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 23Apr2024 to 26Apr2024.  The information on the batch/lot number for BNT162B2 OMI XBB.1.5 will be requested and submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 26Apr2024 to 01May2024.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Nurse.  A 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 15Feb2024 to 20Feb2024.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 71.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Bursa disorder, Cyst
Clinical narrative: Patient called to informed pharmacy that she has developed a cyst size of a golf ball on her right elbow a few days after vaccination.  She went to her primary and was diagnosed with bursa.  She explained that her primary is not completely sure if it was related to the vaccine.  It may be due to her arthritis condition.  No further treatment done by provider at this time.
Age: 40.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient presented to the pharmacy for RSV vaccine on 2/4/2024. We administered on 2/4/2024 however that was outside of seasonal guidelines (Sept to January).
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: None. Vaccine Error. This vaccine dose should not have been given because patient received dose 1 on March 8, 2019 and dose 2 on May 28, 2019.
Age: 11.0
Sex: F
Vaccine: COVID19-2, HPV9, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Wrong COVID-19 vaccine given to patient.  Patient was administered 12+ vaccine, but only 11 years of age at the time of vaccination.  Patient did not experience any adverse effects from the wrong administration.
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Accidentally administered pediatric dose of Havrix Hep A to an adult. Error was caught upon attempting to chart the lot number. Patient notified, provider notified. Second dose of pediatric vaccine administered to total a full adult dose.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Autonomic nervous system imbalance, Chest X-ray, Chest pain, Chills, Dizziness
Clinical narrative: With in hours extremely Ill, fever chills tired.  2 weeks later tired, dizzy  lightheaded when standing, tachycardia rapid HR  when sitting around 105 BPM standing  119-140.. extreme fatigue.  Heart palpitations, chest pain.  Inability to stand for long.  Unable to do college and work job due to the level of fatigue and chest pain and diagnosed with Dysautonomia.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness postural, Dysstasia, Echocardiogram, Educational problem, Electrocardiogram
Clinical narrative: With in hours extremely Ill, fever chills tired.  2 weeks later tired, dizzy  lightheaded when standing, tachycardia rapid HR  when sitting around 105 BPM standing  119-140.. extreme fatigue.  Heart palpitations, chest pain.  Inability to stand for long.  Unable to do college and work job due to the level of fatigue and chest pain and diagnosed with Dysautonomia.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Heart rate increased, Impaired work ability, Loss of personal independence in daily activities, Magnetic resonance imaging heart
Clinical narrative: With in hours extremely Ill, fever chills tired.  2 weeks later tired, dizzy  lightheaded when standing, tachycardia rapid HR  when sitting around 105 BPM standing  119-140.. extreme fatigue.  Heart palpitations, chest pain.  Inability to stand for long.  Unable to do college and work job due to the level of fatigue and chest pain and diagnosed with Dysautonomia.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise, Metabolic function test, Palpitations, Pyrexia, Tachycardia
Clinical narrative: With in hours extremely Ill, fever chills tired.  2 weeks later tired, dizzy  lightheaded when standing, tachycardia rapid HR  when sitting around 105 BPM standing  119-140.. extreme fatigue.  Heart palpitations, chest pain.  Inability to stand for long.  Unable to do college and work job due to the level of fatigue and chest pain and diagnosed with Dysautonomia.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tilt table test
Clinical narrative: With in hours extremely Ill, fever chills tired.  2 weeks later tired, dizzy  lightheaded when standing, tachycardia rapid HR  when sitting around 105 BPM standing  119-140.. extreme fatigue.  Heart palpitations, chest pain.  Inability to stand for long.  Unable to do college and work job due to the level of fatigue and chest pain and diagnosed with Dysautonomia.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting and fever
Age: 46.0
Sex: M
Vaccine: JEV1
Symptoms: Rash, Urticaria
Clinical narrative: Skin break out in hives, rash throughout body.   Took Benadryl which help resolve symptoms withing 48 hours.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given 1 dose of Cominarty on 4/19/2024 without realizing the manufacturer expiration date on the box was 4/16/2024. Patient experienced no adverse effects but called when she noticed on her receipt that it had been expired.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles right waist front and back, right crotch,right hip. Treatment consisted of Valacyclovir hcl 1 gram (10 daily pills) and 5 days of gabapentin 100mg; and cold paks.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations
Clinical narrative: Pinching, pain, and palpitations occurring on left side. Onset 3 hours after vaccination with Covid-like symptoms. Pinching, pain, and palpitations have persisted intermittently (3-4 occasions per week lasting 1-2hours) for years following the dose. No improvement to date.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Chest pain, Chills, Deafness, Disorientation
Clinical narrative: I had very extreme fever, pain, chills, chest pain, nerve pain, brain fog, migraine. It happed very fast within a 1 hour time frame, I went from being fine to being disoriented and so cold I had to huddle under many blankets and turn my heater up while shivering. And since then, I have been stricken with illness after illness. 2-4 times per month, every month since. Including an inner ear infection that caused me to go deaf for over 3 weeks, Shingles for over 4 weeks, Pneumonia and chest flu for over 3 weeks. I believe my immune system and possible my nervous system and or DNA have been damaged permanently. I used to never get sick. I backpacked around the work for a year and never got sick a single time. Now, still to this day, I am still getting sick almost every week and am currently sick with some kind of chest throat illness.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Herpes zoster, Illness, Immune system disorder, Influenza
Clinical narrative: I had very extreme fever, pain, chills, chest pain, nerve pain, brain fog, migraine. It happed very fast within a 1 hour time frame, I went from being fine to being disoriented and so cold I had to huddle under many blankets and turn my heater up while shivering. And since then, I have been stricken with illness after illness. 2-4 times per month, every month since. Including an inner ear infection that caused me to go deaf for over 3 weeks, Shingles for over 4 weeks, Pneumonia and chest flu for over 3 weeks. I believe my immune system and possible my nervous system and or DNA have been damaged permanently. I used to never get sick. I backpacked around the work for a year and never got sick a single time. Now, still to this day, I am still getting sick almost every week and am currently sick with some kind of chest throat illness.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Labyrinthitis, Lower respiratory tract infection, Malaise, Migraine, Neuralgia
Clinical narrative: I had very extreme fever, pain, chills, chest pain, nerve pain, brain fog, migraine. It happed very fast within a 1 hour time frame, I went from being fine to being disoriented and so cold I had to huddle under many blankets and turn my heater up while shivering. And since then, I have been stricken with illness after illness. 2-4 times per month, every month since. Including an inner ear infection that caused me to go deaf for over 3 weeks, Shingles for over 4 weeks, Pneumonia and chest flu for over 3 weeks. I believe my immune system and possible my nervous system and or DNA have been damaged permanently. I used to never get sick. I backpacked around the work for a year and never got sick a single time. Now, still to this day, I am still getting sick almost every week and am currently sick with some kind of chest throat illness.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pharyngitis, Pneumonia, Pyrexia
Clinical narrative: I had very extreme fever, pain, chills, chest pain, nerve pain, brain fog, migraine. It happed very fast within a 1 hour time frame, I went from being fine to being disoriented and so cold I had to huddle under many blankets and turn my heater up while shivering. And since then, I have been stricken with illness after illness. 2-4 times per month, every month since. Including an inner ear infection that caused me to go deaf for over 3 weeks, Shingles for over 4 weeks, Pneumonia and chest flu for over 3 weeks. I believe my immune system and possible my nervous system and or DNA have been damaged permanently. I used to never get sick. I backpacked around the work for a year and never got sick a single time. Now, still to this day, I am still getting sick almost every week and am currently sick with some kind of chest throat illness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Computerised tomogram head normal, Full blood count normal, Laboratory test normal, Seizure
Clinical narrative: On 5/2 pm patient had seizure. No fever prior or after the seizure. Patient was seen in ER and had negative CT scan and labs. No known cause or seizure. No history of seizures before. Child fully recovered.
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: Vaccine exposure during pregnancy; pregnant patient received Arexvy vaccine; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 23-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 25-APR-2024, the patient received Arexvy. On 25-APR-2024, an unknown time after receiving Arexvy, the patient experienced product use in unapproved population (Verbatim: pregnant patient received Arexvy vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Vaccine exposure during pregnancy). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 25-APR-2024 The pharmacist reported that the Arexvy vaccine was administered to pregnant patient, which led to vaccine exposure during pregnancy and product use in unapproved population. The patient gestational age and delivery due date were unknown by the healthcare professional. The reporter consented to follow up.
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Vaccine exposure during pregnancy; pregnant patient received Arexvy vaccine; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 23-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 25-APR-2024, the patient received Arexvy. On 25-APR-2024, an unknown time after receiving Arexvy, the patient experienced product use in unapproved population (Verbatim: pregnant patient received Arexvy vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Vaccine exposure during pregnancy). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 25-APR-2024 The pharmacist reported that the Arexvy vaccine was administered to pregnant patient, which led to vaccine exposure during pregnancy and product use in unapproved population. The patient gestational age and delivery due date were unknown by the healthcare professional. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Chest discomfort, Headache, Influenza virus test negative, Nasal congestion, SARS-CoV-2 test negative
Clinical narrative: She had an adverse reaction to it/ allergic to; wheezing; tightness in chest; trouble breathing, swallowing and talking; trouble breathing, swallowing and talking; trouble breathing, swallowing and talking; hoarseness; weakness; tiredness; headache; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02May2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "High cholesterol" (ongoing); "allergic to pork" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased; ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac disorder; VITAMINS NOS. The following information was reported: ALLERGY TO VACCINE (non-serious) with onset May2024, outcome "unknown", described as "She had an adverse reaction to it/ allergic to"; HEADACHE (non-serious) with onset May2024, outcome "unknown"; DYSPHONIA (non-serious) with onset May2024, outcome "unknown", described as "hoarseness"; CHEST DISCOMFORT (non-serious) with onset May2024, outcome "unknown", described as "tightness in chest"; FATIGUE (non-serious) with onset May2024, outcome "unknown", described as "tiredness"; DYSPNOEA (non-serious), DYSPHAGIA (non-serious), SPEECH DISORDER (non-serious) all with onset May2024, outcome "unknown" and all described as "trouble breathing, swallowing and talking"; ASTHENIA (non-serious) with onset May2024, outcome "unknown", described as "weakness"; WHEEZING (non-serious) with onset May2024, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of allergy to vaccine, wheezing, chest discomfort, dyspnoea, dysphagia, speech disorder, dysphonia, asthenia, fatigue, headache.  Additional information: The patient took Abrysvo on 02May2024 and two days later she had wheezing, tightness in chest, trouble breathing, swallowing and talking and hoarseness, and also weakness, tiredness and headache. It might have even started one day, but then the patient went to the urgent care two days later. On the 5th, the patient took Loratadine and Albuterol and Prednisone and also nose spray, saline nose spray. An allergy pill, Loratadine. when the patient went to the urgent care after the adverse event, test for COVID. The patient was allergic to pork and may be that was why she had this adverse reaction, the patient wanted to know if Abrysvo contain any pork or porcine products like gelatin or glycerin since she had an adverse reaction to it.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Wheezing
Clinical narrative: She had an adverse reaction to it/ allergic to; wheezing; tightness in chest; trouble breathing, swallowing and talking; trouble breathing, swallowing and talking; trouble breathing, swallowing and talking; hoarseness; weakness; tiredness; headache; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02May2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "High cholesterol" (ongoing); "allergic to pork" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased; ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac disorder; VITAMINS NOS. The following information was reported: ALLERGY TO VACCINE (non-serious) with onset May2024, outcome "unknown", described as "She had an adverse reaction to it/ allergic to"; HEADACHE (non-serious) with onset May2024, outcome "unknown"; DYSPHONIA (non-serious) with onset May2024, outcome "unknown", described as "hoarseness"; CHEST DISCOMFORT (non-serious) with onset May2024, outcome "unknown", described as "tightness in chest"; FATIGUE (non-serious) with onset May2024, outcome "unknown", described as "tiredness"; DYSPNOEA (non-serious), DYSPHAGIA (non-serious), SPEECH DISORDER (non-serious) all with onset May2024, outcome "unknown" and all described as "trouble breathing, swallowing and talking"; ASTHENIA (non-serious) with onset May2024, outcome "unknown", described as "weakness"; WHEEZING (non-serious) with onset May2024, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of allergy to vaccine, wheezing, chest discomfort, dyspnoea, dysphagia, speech disorder, dysphonia, asthenia, fatigue, headache.  Additional information: The patient took Abrysvo on 02May2024 and two days later she had wheezing, tightness in chest, trouble breathing, swallowing and talking and hoarseness, and also weakness, tiredness and headache. It might have even started one day, but then the patient went to the urgent care two days later. On the 5th, the patient took Loratadine and Albuterol and Prednisone and also nose spray, saline nose spray. An allergy pill, Loratadine. when the patient went to the urgent care after the adverse event, test for COVID. The patient was allergic to pork and may be that was why she had this adverse reaction, the patient wanted to know if Abrysvo contain any pork or porcine products like gelatin or glycerin since she had an adverse reaction to it.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Allergy to vaccine, Asthenia, Chest discomfort, Dysphagia, Dysphonia
Clinical narrative: She had an adverse reaction to it/ allergic to; wheezing; tightness in chest; trouble breathing, swallowing and talking; trouble breathing, swallowing and talking; trouble breathing, swallowing and talking; hoarseness; weakness; tiredness; headache; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02May2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "High cholesterol" (ongoing); "allergic to pork" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased; ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac disorder; VITAMINS NOS. The following information was reported: ALLERGY TO VACCINE (non-serious) with onset May2024, outcome "unknown", described as "She had an adverse reaction to it/ allergic to"; HEADACHE (non-serious) with onset May2024, outcome "unknown"; DYSPHONIA (non-serious) with onset May2024, outcome "unknown", described as "hoarseness"; CHEST DISCOMFORT (non-serious) with onset May2024, outcome "unknown", described as "tightness in chest"; FATIGUE (non-serious) with onset May2024, outcome "unknown", described as "tiredness"; DYSPNOEA (non-serious), DYSPHAGIA (non-serious), SPEECH DISORDER (non-serious) all with onset May2024, outcome "unknown" and all described as "trouble breathing, swallowing and talking"; ASTHENIA (non-serious) with onset May2024, outcome "unknown", described as "weakness"; WHEEZING (non-serious) with onset May2024, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of allergy to vaccine, wheezing, chest discomfort, dyspnoea, dysphagia, speech disorder, dysphonia, asthenia, fatigue, headache.  Additional information: The patient took Abrysvo on 02May2024 and two days later she had wheezing, tightness in chest, trouble breathing, swallowing and talking and hoarseness, and also weakness, tiredness and headache. It might have even started one day, but then the patient went to the urgent care two days later. On the 5th, the patient took Loratadine and Albuterol and Prednisone and also nose spray, saline nose spray. An allergy pill, Loratadine. when the patient went to the urgent care after the adverse event, test for COVID. The patient was allergic to pork and may be that was why she had this adverse reaction, the patient wanted to know if Abrysvo contain any pork or porcine products like gelatin or glycerin since she had an adverse reaction to it.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Dyspnoea, Fatigue, Headache, SARS-CoV-2 test, Speech disorder
Clinical narrative: She had an adverse reaction to it/ allergic to; wheezing; tightness in chest; trouble breathing, swallowing and talking; trouble breathing, swallowing and talking; trouble breathing, swallowing and talking; hoarseness; weakness; tiredness; headache; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02May2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "High cholesterol" (ongoing); "allergic to pork" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased; ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac disorder; VITAMINS NOS. The following information was reported: ALLERGY TO VACCINE (non-serious) with onset May2024, outcome "unknown", described as "She had an adverse reaction to it/ allergic to"; HEADACHE (non-serious) with onset May2024, outcome "unknown"; DYSPHONIA (non-serious) with onset May2024, outcome "unknown", described as "hoarseness"; CHEST DISCOMFORT (non-serious) with onset May2024, outcome "unknown", described as "tightness in chest"; FATIGUE (non-serious) with onset May2024, outcome "unknown", described as "tiredness"; DYSPNOEA (non-serious), DYSPHAGIA (non-serious), SPEECH DISORDER (non-serious) all with onset May2024, outcome "unknown" and all described as "trouble breathing, swallowing and talking"; ASTHENIA (non-serious) with onset May2024, outcome "unknown", described as "weakness"; WHEEZING (non-serious) with onset May2024, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of allergy to vaccine, wheezing, chest discomfort, dyspnoea, dysphagia, speech disorder, dysphonia, asthenia, fatigue, headache.  Additional information: The patient took Abrysvo on 02May2024 and two days later she had wheezing, tightness in chest, trouble breathing, swallowing and talking and hoarseness, and also weakness, tiredness and headache. It might have even started one day, but then the patient went to the urgent care two days later. On the 5th, the patient took Loratadine and Albuterol and Prednisone and also nose spray, saline nose spray. An allergy pill, Loratadine. when the patient went to the urgent care after the adverse event, test for COVID. The patient was allergic to pork and may be that was why she had this adverse reaction, the patient wanted to know if Abrysvo contain any pork or porcine products like gelatin or glycerin since she had an adverse reaction to it.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Age: 12.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: had antibody testing done in which it came back "non-reactive"; This spontaneous report has been received from a certified nurse practitioner (C.N.P) (also reporter as nurse prescriber) and refers to a 12-year-old patient who gender was not provided.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On an unknown date, the patient received unknown hepatitis B vaccine (manufacturer unknown) reporter cannot recall if it was hepatitis b vaccine (recombinant) (RECOMBIVAX HB) or other company vaccine) as prophylaxis (formulation, dose, vaccine scheme, route of administration, anatomical location, lot number and expiration date were not provided).   On unspecified date, the patient had an antibody testing done in which it came back "non-reactive" (hepatitis B antibody negative). The outcome and the causal relationship between the event and the suspect vaccine were not reported.   This is one of two reports from the same reporter.   Lot # is being requested and will be submitted if received.; Sender's Comments:  US-009507513-2404USA007746:02585328
Sex: F
Vaccine: MMRV
Symptoms: Immediate post-injection reaction, Skin discolouration, Vasodilatation, Weight decreased
Clinical narrative: Immediately after the dose was administered , the patient's forehead veins looked like they popped and there were little marks on forehead; Weight loss; This spontaneous report was received from a medical assistant referring to a 13-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions included ear infection and food allergy. Concomitant medications included hepatitis a vaccine (+) inactivated (manufacturer unknown), pneumococcal vaccination (pneumococcal 23v polysaccharide vaccine (manufacturer unknown) or pneumococcal 15v conj vaccine (crm197) (manufacturer unknown)), haemophilus b conjugate vaccine (meningococcal protein conjugate)(manufacturer unknown).  On 10-APR-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 dose, lot #W038809, expiration date: 04-JUN-2024, administered subcutaneously for immunization for the prevention of measles, mumps, rubella, and varicella (strength was not provided). It was noted that it was supposed to be administered measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX), but they administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).   On that same date, after the dose was administered, the patient's forehead veins looked like they popped and there were little marks on the forehead, the patient was treated with diphenhydramine hydrochloride  (BENADRYL). On 15-APR-2024, the reporter saw the patient in the office, and the marks were resolved.  On 26-APR-2024, a patient's family member called to the reporter's office and reported that the patient was losing weight (start date not provided). At the time of reporting, the outcome of the event weight loss was unknown.   The causal relationship between immediately after the dose was administered, the patient's forehead veins looked like they popped and there were little marks on the forehead and weight loss; and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Physician states that no symptomatic adverse events were known at this time; accidental administration of ROTATEQ to a patient intramuscularly instead of by mouth.; This spontaneous report was received from a physician and refers to a 9-week-old female patient. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 30-APR-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter/once, lot #1975783, expiration date: 12-OCT-2024, administered intramuscular (IM) instead of by mouth (strength was not provided) (Incorrect route of product administration) for prophylaxis. Physician stated that a new nurse accidently drew up on the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) on the morning of 30-APR-2024 during a clinic and administered the vaccine IM. Physician stated that no symptomatic adverse events were known at this time. The vaccine was administered in the community health center inc. No additional information was available. No additional adverse event nor product quality complaint reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; VAQTA was administered after a temperature excursion; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-APR-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (once, lot #X025482 has been verified to be a valid lot number, expiration date: 12-APR-2025; dose, route and strength were not provided) for prophylaxis. On an unknown date, the vaccine mentioned above had a temperature excursion of 32.9 Fahrenheit degree for 3 hours 18 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2405USA000864:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Medical assistant reported VAQTA was administered after a temperature excursion to patient; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-APR-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (once, lot #X025482 has been verified to be a valid lot number, expiration date: 12-APR-2025; dose, route and strength were not provided) for prophylaxis. On an unknown date, the vaccine mentioned above had a temperature excursion of 32.9 Fahrenheit degree for 3 hours 18 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event).  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2405USA000864:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant reported RECOMBIVAX HB was administered after a temperature excursion to patient. Date of administration: 4/19/2024.  Names of vaccines involved (including lot/exp): RECOMBIVAX HB (X006977 10/01/2025) Temperature: 32.9°F Time frame; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 19-APR-2024, the patient was vaccinated with hepatitis b vaccine (recombinant) (rHA) (RECOMBIVAX HB) intramuscular injection, once, for prophylaxis (lot #X006977, expiration date: 01-OCT-2025, strength, dose and route of administration were not provided), after a temperature excursion (temperature: 32.9 F, time frame: 3 hours 18 minutes) (product storage error). No additional adverse events were reported (no adverse event). Operator of device: health professional.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Gait disturbance
Clinical narrative: The night after getting the 2nd 2019-nCoV Vaccine I was in bed.  Around midnight I stood to use the bathroom and felt a clinch in my chest.  I took a few steps and the clinch tightened, after each following step the pain intensified and was on the floor after only 4-5 feet.  I was grabbing at my heart thinking I might be having or was about to have a heart attack.  After 2-3 minutes of this it gradually went away leaving me terrified as to what happened and what may happen in the future.  I describe the pain as having a powerful squeezing or pulling right in the middle of my chest repeated every 10 or 15 seconds, each getting more powerful and painful as they go.  This was my adverse reaction the same night after receiving the injection.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Appetite disorder, Crying, Diarrhoea, Lethargy, Malaise
Clinical narrative: change in eating habit; lethargy; crying; general malaise; bad fever; severe diarrhea; Initial information was received on 23-Apr-2024 regarding an unsolicited valid  non-serious case received from Non healthcare professional (patient's father).  This case involves a 30 months old female patient who experienced severe diarrhea, change in eating habit, lethargy, crying, bad fever and general malaise after receiving influenza quadrival A-B vaccine [Fluzone quadrivalent].  The patient's past vaccination(s) included influenza vaccine (received 3 flu vaccines: two in 2021, one in 2022). The patient's past medical history, medical treatment(s) and family history were not provided.   On 19-Apr-2024, the patient received a 0.5 ml dose of suspect influenza quadrival A-B vaccine, Suspension for injection (Lot:U8203EA, expiry date: 30-Jun-2024, strength:standard) via intramuscular route in unknown administration site for Immunisation.  On 19-Apr-2024 the patient had severe diarrhea (diarrhoea) (Latency: same day) following the administration of influenza quadrival A-B vaccine.  On 20-Apr-2024 the patient had bad fever (pyrexia) (Latency:1 day) following the administration of influenza quadrival A-B vaccine.  On an unknown date the patient had change in eating habit (eating disorder), lethargy, crying, general malaise (malaise) (unknown latency) following the administration of influenza quadrival A-B vaccine.  Reportedly: his child experiences severe diarrhea, change in eating habit and crying, since Friday after getting her shot of Fluzone Quadrivalent at the doctor's office after 3:00pm  Action taken: not applicable.  The patient was treated with paracetamol (Tylenol) for Pyrexia. It was not reported if the patient received a corrective treatment for the events (diarrhoea, eating disorder, lethargy, crying and malaise).  At time of reporting, the outcome was Not Recovered / Not Resolved for events diarrhoea, eating disorder, lethargy, crying and malaise and Recovered / Resolved on an unknown date in 2024 for the event pyrexia.  Additional information was received on 23-Apr-2024 from Non healthcare professional: Age, Age group, New events (lethargy, malaise, Pyrexia), Suspect route, onset date, dose, Vaccination history were added. Event outcome updated. Text amended accordingly.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: change in eating habit; lethargy; crying; general malaise; bad fever; severe diarrhea; Initial information was received on 23-Apr-2024 regarding an unsolicited valid  non-serious case received from Non healthcare professional (patient's father).  This case involves a 30 months old female patient who experienced severe diarrhea, change in eating habit, lethargy, crying, bad fever and general malaise after receiving influenza quadrival A-B vaccine [Fluzone quadrivalent].  The patient's past vaccination(s) included influenza vaccine (received 3 flu vaccines: two in 2021, one in 2022). The patient's past medical history, medical treatment(s) and family history were not provided.   On 19-Apr-2024, the patient received a 0.5 ml dose of suspect influenza quadrival A-B vaccine, Suspension for injection (Lot:U8203EA, expiry date: 30-Jun-2024, strength:standard) via intramuscular route in unknown administration site for Immunisation.  On 19-Apr-2024 the patient had severe diarrhea (diarrhoea) (Latency: same day) following the administration of influenza quadrival A-B vaccine.  On 20-Apr-2024 the patient had bad fever (pyrexia) (Latency:1 day) following the administration of influenza quadrival A-B vaccine.  On an unknown date the patient had change in eating habit (eating disorder), lethargy, crying, general malaise (malaise) (unknown latency) following the administration of influenza quadrival A-B vaccine.  Reportedly: his child experiences severe diarrhea, change in eating habit and crying, since Friday after getting her shot of Fluzone Quadrivalent at the doctor's office after 3:00pm  Action taken: not applicable.  The patient was treated with paracetamol (Tylenol) for Pyrexia. It was not reported if the patient received a corrective treatment for the events (diarrhoea, eating disorder, lethargy, crying and malaise).  At time of reporting, the outcome was Not Recovered / Not Resolved for events diarrhoea, eating disorder, lethargy, crying and malaise and Recovered / Resolved on an unknown date in 2024 for the event pyrexia.  Additional information was received on 23-Apr-2024 from Non healthcare professional: Age, Age group, New events (lethargy, malaise, Pyrexia), Suspect route, onset date, dose, Vaccination history were added. Event outcome updated. Text amended accordingly.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion product administered with no reported adverse event; Initial information received on 30-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 months old female patient who had received Hib (Prp/T) Vaccine [Act-Hib] after temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Apr-2024, the patient received a unknown dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Immunization and temperature excursion product administered with no reported adverse event (poor quality product administered) (latency: same day). Information on the batch number was requested.   Reportedly: "Wire was not completely attached to the data logger Max/Lowest Temp reached: 10.76 F (Fahrenheit) -13hrs 50minutes 10.69F - 8hrs 21 mins Human Error: NO; the extended stability data was not cover the excursion."  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 the 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.
Age: 51.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Nausea
Clinical narrative: Severe stomach cramps, nausea, headache, and diarrhea. Symptoms lasted 4 days. Did not take any further doses of the oral vaccine.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Back pain, Gait disturbance, Swelling
Clinical narrative: severe back and joint pain with swelling unable to walk much
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Swelling and firmness at injection site - visit with physician and medication prescribed