chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysmenorrhoea, Eye pain, Headache, Heavy menstrual bleeding
Clinical narrative: Starting the night of my first vaccine, I had nerve pain shooting from my shoulders up to the top of my head and behind my eyes, the occipital nerves (on both sides). It still hasn't gone away, sometimes the pain hurts so bad it drops me to the floor until it decides to calm down. Every menstrual cycle I have had since the vaccines has been extremely heavy and very painful, they make me sick and put me in bed for days. None of these conditions I've described have lightened up very much.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Neuralgia, Pain
Clinical narrative: Starting the night of my first vaccine, I had nerve pain shooting from my shoulders up to the top of my head and behind my eyes, the occipital nerves (on both sides). It still hasn't gone away, sometimes the pain hurts so bad it drops me to the floor until it decides to calm down. Every menstrual cycle I have had since the vaccines has been extremely heavy and very painful, they make me sick and put me in bed for days. None of these conditions I've described have lightened up very much.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Injection site pain, Injection site swelling, Rash, Rash pruritic
Clinical narrative: Pain and swelling at site that resolved followed by wide spread rash. Scatterd bumps (red and skin colored) primarilly on torso and extremities.  Also very itchy.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Condition aggravated, Dry skin, Echocardiogram, Electrocardiogram
Clinical narrative: The morning following my second vaccine, I woke up with my face, eyes, lips and throat completely swollen. One week later my heart condition (SVT) became uncontrollable/more severe. My skin on my face became extremely dry and peeling for weeks. I was pregnant and had a miscarriage one month later.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Eye swelling, Human chorionic gonadotropin, Lip swelling, Pharyngeal swelling
Clinical narrative: The morning following my second vaccine, I woke up with my face, eyes, lips and throat completely swollen. One week later my heart condition (SVT) became uncontrollable/more severe. My skin on my face became extremely dry and peeling for weeks. I was pregnant and had a miscarriage one month later.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Supraventricular tachycardia, Swelling face, Ultrasound pelvis, Uterine dilation and curettage
Clinical narrative: The morning following my second vaccine, I woke up with my face, eyes, lips and throat completely swollen. One week later my heart condition (SVT) became uncontrollable/more severe. My skin on my face became extremely dry and peeling for weeks. I was pregnant and had a miscarriage one month later.
Age: 1.25
Sex: F
Vaccine: COVID19, DTAP, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: inadvertently given the 10 mcg dose of Pfizer COVID vaccine by nursing staff (instead of the appropriate 3 mcg dose) - no signs/symptoms of adverse outcome
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Urticaria
Clinical narrative: after recieving my third vaccine (booster) I started having hives and brain fog. Its been over a month and I am still suffering.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Angina pectoris, Aphthous ulcer, Chills, Facial pain, Hyperhidrosis
Clinical narrative: My son is having a serious allergic reaction to the Gardasil vaccination. Within several hours of receiving it, his face began hurting, and his lips began swelling up. Then, he developed chills and a fever and broke out in canker sores within his mouth. He woke up during the night screaming in pain and soaked in sweat. Now, his face swelling has worsened. The shape of his nose is now distorted due to the swelling, and his left eye began swelling shut. He is now claiming that his heart is hurting. We took him to the doctor's office earlier this afternoon, but now that it has worsened further, we have taken him to a small local hospital. I know that nobody wants to admit that this is linked to the vaccination, but I have worked in the pharmaceutical industry for 20 years, and it seems highly probable that the administration of the Gardasil vaccination is the causation of these unusual and rapid onset of adverse health effects.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Hypersensitivity, Lip swelling, Night sweats, Pain, Pyrexia
Clinical narrative: My son is having a serious allergic reaction to the Gardasil vaccination. Within several hours of receiving it, his face began hurting, and his lips began swelling up. Then, he developed chills and a fever and broke out in canker sores within his mouth. He woke up during the night screaming in pain and soaked in sweat. Now, his face swelling has worsened. The shape of his nose is now distorted due to the swelling, and his left eye began swelling shut. He is now claiming that his heart is hurting. We took him to the doctor's office earlier this afternoon, but now that it has worsened further, we have taken him to a small local hospital. I know that nobody wants to admit that this is linked to the vaccination, but I have worked in the pharmaceutical industry for 20 years, and it seems highly probable that the administration of the Gardasil vaccination is the causation of these unusual and rapid onset of adverse health effects.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Screaming, Sleep disorder, Swelling face, Swelling of eyelid
Clinical narrative: My son is having a serious allergic reaction to the Gardasil vaccination. Within several hours of receiving it, his face began hurting, and his lips began swelling up. Then, he developed chills and a fever and broke out in canker sores within his mouth. He woke up during the night screaming in pain and soaked in sweat. Now, his face swelling has worsened. The shape of his nose is now distorted due to the swelling, and his left eye began swelling shut. He is now claiming that his heart is hurting. We took him to the doctor's office earlier this afternoon, but now that it has worsened further, we have taken him to a small local hospital. I know that nobody wants to admit that this is linked to the vaccination, but I have worked in the pharmaceutical industry for 20 years, and it seems highly probable that the administration of the Gardasil vaccination is the causation of these unusual and rapid onset of adverse health effects.
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Ear discomfort, Tinnitus
Clinical narrative: After receiving my second Covid 19 vaccine, within a day or two my ear felt stopped up. I thought I was going to get a cold or something. It continued to feel stopped up. Tinnitus started. I thought perhaps I had built up wax in my ear. I used ear drops to try to clear it out. Finally went to my family physician. She said everything looked fine. Referred me to an ENT. First thing he did was a hearing test. I had lost over 80% of my hearing. Tried treating it with steroids but, it was too late. The loss is permanent. If I had known this was a possible side effect, I could have reacted quicker to be treated. At least I would have had a CHANCE to save my hearing.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Dehydration, Dizziness
Clinical narrative: Husband got home at 2:30 pm Friday she was well. Went out to dinner she was fine. Went to bed at 9 pm. Saturday 5 am she wakes up dehydrated and vomiting. Passed away 5:45 am
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Dehydration, Vomiting
Clinical narrative: Husband got home at 2:30 pm Friday she was well. Went out to dinner she was fine. Went to bed at 9 pm. Saturday 5 am she wakes up dehydrated and vomiting. Passed away 5:45 am
Age: 61.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: I received the Prevnar 20 pneumonia vaccine Lot # FF8005 via syringe on the upper right deltoid  at the pharmacy, administered by RPh on 4/29/2022.  I started having soreness on the right deltoid where the shot was administered.  Within 24 hours the area of the right deltoid had become inflamed and bulged with a hardness in the area.  The soreness continued for weeks.  One week after the administration of the shot, the large football shaped raised bulge on my right deltoid existed and the injection point where vaccine was administered continued to bleed out of the injection hole if I squeezed the inflammed area.  Upon taking a hot shower, blood would spread all the way down to my elbow to about my shabove my shoulder.  The injection pain still existed.   I went to the pharmacy to repost the continued adverse reaction and they offered no advice.  The pharmacy indicated that they would report the adverse reaction to VAERS.   Now, 3 months have passed  I still have chronic pain due to some type of nerve damage that has been caused by the vaccine.  My arm is constantly aggravating me causing me to lose sleep at nights when I feel the agitating condtion.  I went to see my primary physician about this and showed him all of my dated photos showing the adverse reaction and he indicated that the vaccination is the cause of this reaction.  He mentioned that I could possibly go through some type of cortisone treatment to see if pain could be reduced.  I take 400 - 600  mg of advil 3 or 4 times daily and get no pain relief from this adverse effect   I went to see a orthopedic arm specialist on 8/19/2022 to get his view on this and he indicated that he has seen quite a few patients that have complained of this ongoing pain going on for even a year  with some patients having continued pain as long as 1 to 2 years.  I  cannot tolerate this situation and need to get some type of assitance from the manufacturer of the vaccine to remedy this problem immediately.
Age: 61.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Agitation, Immunisation reaction, Injection site haemorrhage, Injection site induration, Injection site inflammation
Clinical narrative: I received the Prevnar 20 pneumonia vaccine Lot # FF8005 via syringe on the upper right deltoid  at the pharmacy, administered by RPh on 4/29/2022.  I started having soreness on the right deltoid where the shot was administered.  Within 24 hours the area of the right deltoid had become inflamed and bulged with a hardness in the area.  The soreness continued for weeks.  One week after the administration of the shot, the large football shaped raised bulge on my right deltoid existed and the injection point where vaccine was administered continued to bleed out of the injection hole if I squeezed the inflammed area.  Upon taking a hot shower, blood would spread all the way down to my elbow to about my shabove my shoulder.  The injection pain still existed.   I went to the pharmacy to repost the continued adverse reaction and they offered no advice.  The pharmacy indicated that they would report the adverse reaction to VAERS.   Now, 3 months have passed  I still have chronic pain due to some type of nerve damage that has been caused by the vaccine.  My arm is constantly aggravating me causing me to lose sleep at nights when I feel the agitating condtion.  I went to see my primary physician about this and showed him all of my dated photos showing the adverse reaction and he indicated that the vaccination is the cause of this reaction.  He mentioned that I could possibly go through some type of cortisone treatment to see if pain could be reduced.  I take 400 - 600  mg of advil 3 or 4 times daily and get no pain relief from this adverse effect   I went to see a orthopedic arm specialist on 8/19/2022 to get his view on this and he indicated that he has seen quite a few patients that have complained of this ongoing pain going on for even a year  with some patients having continued pain as long as 1 to 2 years.  I  cannot tolerate this situation and need to get some type of assitance from the manufacturer of the vaccine to remedy this problem immediately.
Age: 61.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Injection site pain, Injection site swelling, Limb discomfort, Nerve injury, Pain
Clinical narrative: I received the Prevnar 20 pneumonia vaccine Lot # FF8005 via syringe on the upper right deltoid  at the pharmacy, administered by RPh on 4/29/2022.  I started having soreness on the right deltoid where the shot was administered.  Within 24 hours the area of the right deltoid had become inflamed and bulged with a hardness in the area.  The soreness continued for weeks.  One week after the administration of the shot, the large football shaped raised bulge on my right deltoid existed and the injection point where vaccine was administered continued to bleed out of the injection hole if I squeezed the inflammed area.  Upon taking a hot shower, blood would spread all the way down to my elbow to about my shabove my shoulder.  The injection pain still existed.   I went to the pharmacy to repost the continued adverse reaction and they offered no advice.  The pharmacy indicated that they would report the adverse reaction to VAERS.   Now, 3 months have passed  I still have chronic pain due to some type of nerve damage that has been caused by the vaccine.  My arm is constantly aggravating me causing me to lose sleep at nights when I feel the agitating condtion.  I went to see my primary physician about this and showed him all of my dated photos showing the adverse reaction and he indicated that the vaccination is the cause of this reaction.  He mentioned that I could possibly go through some type of cortisone treatment to see if pain could be reduced.  I take 400 - 600  mg of advil 3 or 4 times daily and get no pain relief from this adverse effect   I went to see a orthopedic arm specialist on 8/19/2022 to get his view on this and he indicated that he has seen quite a few patients that have complained of this ongoing pain going on for even a year  with some patients having continued pain as long as 1 to 2 years.  I  cannot tolerate this situation and need to get some type of assitance from the manufacturer of the vaccine to remedy this problem immediately.
Age: 61.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Sleep disorder
Clinical narrative: I received the Prevnar 20 pneumonia vaccine Lot # FF8005 via syringe on the upper right deltoid  at the pharmacy, administered by RPh on 4/29/2022.  I started having soreness on the right deltoid where the shot was administered.  Within 24 hours the area of the right deltoid had become inflamed and bulged with a hardness in the area.  The soreness continued for weeks.  One week after the administration of the shot, the large football shaped raised bulge on my right deltoid existed and the injection point where vaccine was administered continued to bleed out of the injection hole if I squeezed the inflammed area.  Upon taking a hot shower, blood would spread all the way down to my elbow to about my shabove my shoulder.  The injection pain still existed.   I went to the pharmacy to repost the continued adverse reaction and they offered no advice.  The pharmacy indicated that they would report the adverse reaction to VAERS.   Now, 3 months have passed  I still have chronic pain due to some type of nerve damage that has been caused by the vaccine.  My arm is constantly aggravating me causing me to lose sleep at nights when I feel the agitating condtion.  I went to see my primary physician about this and showed him all of my dated photos showing the adverse reaction and he indicated that the vaccination is the cause of this reaction.  He mentioned that I could possibly go through some type of cortisone treatment to see if pain could be reduced.  I take 400 - 600  mg of advil 3 or 4 times daily and get no pain relief from this adverse effect   I went to see a orthopedic arm specialist on 8/19/2022 to get his view on this and he indicated that he has seen quite a few patients that have complained of this ongoing pain going on for even a year  with some patients having continued pain as long as 1 to 2 years.  I  cannot tolerate this situation and need to get some type of assitance from the manufacturer of the vaccine to remedy this problem immediately.
Age: 62.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: CSF protein increased, Chills, Chronic sinusitis, Computerised tomogram abnormal, Epididymitis
Clinical narrative: Diagnosed Guillain-Barree Syndrome (GBS). Patient experienced severe weakness and motor control of legs,   Experienced numbness/tingling in feet to nipple line, fingertips to shoulders and in neck upwards to jaw.  Initial presentation on or about July 3.  Hospitalized on July 10th.  No reflexes noted in knees, ankles or arms.    Treatment - 5 Immunoglobulin infusions given 24 hours apart.  Patient continues to have mild tingling in hands and feet with mild fatigue and weakness.
Age: 62.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Immunoglobulin therapy, Loss of personal independence in daily activities, Lumbar puncture abnormal
Clinical narrative: Diagnosed Guillain-Barree Syndrome (GBS). Patient experienced severe weakness and motor control of legs,   Experienced numbness/tingling in feet to nipple line, fingertips to shoulders and in neck upwards to jaw.  Initial presentation on or about July 3.  Hospitalized on July 10th.  No reflexes noted in knees, ankles or arms.    Treatment - 5 Immunoglobulin infusions given 24 hours apart.  Patient continues to have mild tingling in hands and feet with mild fatigue and weakness.
Age: 62.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Muscular weakness, Paraesthesia, Pyrexia
Clinical narrative: Diagnosed Guillain-Barree Syndrome (GBS). Patient experienced severe weakness and motor control of legs,   Experienced numbness/tingling in feet to nipple line, fingertips to shoulders and in neck upwards to jaw.  Initial presentation on or about July 3.  Hospitalized on July 10th.  No reflexes noted in knees, ankles or arms.    Treatment - 5 Immunoglobulin infusions given 24 hours apart.  Patient continues to have mild tingling in hands and feet with mild fatigue and weakness.
Age: 62.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Areflexia, Computerised tomogram normal, Electromyogram normal, Fatigue, Guillain-Barre syndrome
Clinical narrative: Diagnosed Guillain-Barree Syndrome (GBS). Patient experienced severe weakness and motor control of legs,   Experienced numbness/tingling in feet to nipple line, fingertips to shoulders and in neck upwards to jaw.  Initial presentation on or about July 3.  Hospitalized on July 10th.  No reflexes noted in knees, ankles or arms.    Treatment - 5 Immunoglobulin infusions given 24 hours apart.  Patient continues to have mild tingling in hands and feet with mild fatigue and weakness.
Age: 62.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture abnormal, Magnetic resonance imaging head normal, Magnetic resonance imaging neck
Clinical narrative: Diagnosed Guillain-Barree Syndrome (GBS). Patient experienced severe weakness and motor control of legs,   Experienced numbness/tingling in feet to nipple line, fingertips to shoulders and in neck upwards to jaw.  Initial presentation on or about July 3.  Hospitalized on July 10th.  No reflexes noted in knees, ankles or arms.    Treatment - 5 Immunoglobulin infusions given 24 hours apart.  Patient continues to have mild tingling in hands and feet with mild fatigue and weakness.
Age: 62.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Magnetic resonance imaging spinal normal, Motor dysfunction, Muscular weakness, Paraesthesia
Clinical narrative: Diagnosed Guillain-Barree Syndrome (GBS). Patient experienced severe weakness and motor control of legs,   Experienced numbness/tingling in feet to nipple line, fingertips to shoulders and in neck upwards to jaw.  Initial presentation on or about July 3.  Hospitalized on July 10th.  No reflexes noted in knees, ankles or arms.    Treatment - 5 Immunoglobulin infusions given 24 hours apart.  Patient continues to have mild tingling in hands and feet with mild fatigue and weakness.
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain lower, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: pain at inj site   then on 7/11/22 :fever, headache, fatigue, chills, sweating ,mailase,loss of appetite,abdominal pain . all of this are common side effects of vaccine,   this was already reported to gsk (manuf), information subsequently sent to rx
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hyperhidrosis, Inappropriate schedule of product administration, Injection site pain, Malaise, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: pain at inj site   then on 7/11/22 :fever, headache, fatigue, chills, sweating ,mailase,loss of appetite,abdominal pain . all of this are common side effects of vaccine,   this was already reported to gsk (manuf), information subsequently sent to rx
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: pain at inj site   then on 7/11/22 :fever, headache, fatigue, chills, sweating ,mailase,loss of appetite,abdominal pain . all of this are common side effects of vaccine,   this was already reported to gsk (manuf), information subsequently sent to rx
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: pain at inj site   then on 7/11/22 :fever, headache, fatigue, chills, sweating ,mailase,loss of appetite,abdominal pain . all of this are common side effects of vaccine,   this was already reported to gsk (manuf), information subsequently sent to rx
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hyperhidrosis, Injection site pain, Lethargy, Malaise, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: pain at inj site   then on 7/11/22 :fever, headache, fatigue, chills, sweating ,mailase,loss of appetite,abdominal pain . all of this are common side effects of vaccine,   this was already reported to gsk (manuf), information subsequently sent to rx
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, CSF culture, Chest X-ray, Culture, Magnetic resonance imaging
Clinical narrative: She said was very painful; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 2, 0.3 ml single (Lot number: EW0169, Expiration Date: Aug2021) at the age of 56 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement; ATENOLOL taken for blood pressure measurement; NIFEDIPINE taken for blood pressure measurement. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML, SINGLE, Lot number: EW0150, Anatomical Location: Left deltoid, Administration time: Afternoon around 12 pm, Expiry date: Jul2021), administration date: 28Jul2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "She said was very painful". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, patient had a history of diabetes and high blood pressure and she confirmed was diagnosed before taking Paxlovid and receiving Pfizer Covid-19 vaccines. She checked her blood pressure every day and no high blood pressure or normal or controlled by medications and she took 3 blood pressure medications,  Lisinopril, Atenolol, and Nifedipine. The patient did not receive any additional vaccine administered on same date of the Pfizer Suspect. Prior Vaccinations(within 4 weeks), the patient did not receive other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Prior to vaccination, patient did not experience any adverse event. The patient had no relevant test.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: She said was very painful; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 2, 0.3 ml single (Lot number: EW0169, Expiration Date: Aug2021) at the age of 56 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement; ATENOLOL taken for blood pressure measurement; NIFEDIPINE taken for blood pressure measurement. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML, SINGLE, Lot number: EW0150, Anatomical Location: Left deltoid, Administration time: Afternoon around 12 pm, Expiry date: Jul2021), administration date: 28Jul2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "She said was very painful". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, patient had a history of diabetes and high blood pressure and she confirmed was diagnosed before taking Paxlovid and receiving Pfizer Covid-19 vaccines. She checked her blood pressure every day and no high blood pressure or normal or controlled by medications and she took 3 blood pressure medications,  Lisinopril, Atenolol, and Nifedipine. The patient did not receive any additional vaccine administered on same date of the Pfizer Suspect. Prior Vaccinations(within 4 weeks), the patient did not receive other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Prior to vaccination, patient did not experience any adverse event. The patient had no relevant test.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Pain
Clinical narrative: She said was very painful; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 2, 0.3 ml single (Lot number: EW0169, Expiration Date: Aug2021) at the age of 56 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement; ATENOLOL taken for blood pressure measurement; NIFEDIPINE taken for blood pressure measurement. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML, SINGLE, Lot number: EW0150, Anatomical Location: Left deltoid, Administration time: Afternoon around 12 pm, Expiry date: Jul2021), administration date: 28Jul2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "She said was very painful". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, patient had a history of diabetes and high blood pressure and she confirmed was diagnosed before taking Paxlovid and receiving Pfizer Covid-19 vaccines. She checked her blood pressure every day and no high blood pressure or normal or controlled by medications and she took 3 blood pressure medications,  Lisinopril, Atenolol, and Nifedipine. The patient did not receive any additional vaccine administered on same date of the Pfizer Suspect. Prior Vaccinations(within 4 weeks), the patient did not receive other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Prior to vaccination, patient did not experience any adverse event. The patient had no relevant test.
Age: 1.17
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Vomiting and nausea.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received the first dose of GARDASIL 9 in Aug 2019 and then never received anymore doses; no adverse event; This spontaneous report was received from a pharmacist referring to a currently 14-year-old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On an unknown date in August 2019, the patient received the first dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered once as prophylaxis (strength, route of administration, anatomical location, dose, lot number and expiration date were not reported) and then never received any more doses (Inappropriate schedule of product administration). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: No additional AE reported.; a syringe of VAXNUVANCE broke when the needle was attached.; the patient was administered the full dose of VAXNUVANACE from the syringe involved in the product  compliant; This spontaneous report was received from an office manager and referred to a patient of unknown age and gender. The medical history, current conditions and concomitant medications were not provided.  On 22-JUL-2022, awhen the needle was attached to pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), the interior portion of the syringe where the luer-lock was located broke (Syringe issue). The syringe did not broken into 2 or more pieces. The tip of the syringe or Luer lock adaptor did not loose or broken off of the syringe tip. There was no difficulty to attach the syringe needle to the syringe and the needle was 25Dx1 inch eclipse needle. The syringe tip cap attached properly prior to use. The syringe tray intact and undamaged on receipt. The cellophane covered the syringe tray intact and was completely sealed. The syringe carton did not damage prior to use.   Although the luer-lock broke, the vaccine was still able to be administered. Then, on the same day (22-JUL-2022), the patient was vaccinated with the full dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (dose: 0.5 milliliter, lot #U036156, expiration date: 25-MAY-2023; route and strength were unknown) for prophylaxis (Poor quality product administered). A biohazard mailer for retrieval of the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was arranged. On 28-JUL-2022, the product was returned. The pictures of the defective syringe were submitted. No additional information provided. No additional AE reported.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Expired product administered
Clinical narrative: No adverse event; an expired dose of ROTATEQ was administered to a patient.; This spontaneous report was received from a medical assistant referring to a 4-month-old female patient. The patient had no known drug allergies (NKDA). The patient had history included hypoglycemia newborn, large for gestational age and single birth delivered by caesarean. Concomitant vaccine included pneumococcal conjugate vaccine (PCV13) (lot: FC0416).  The patient's concurrent conditions were not reported.  The patient was evaluated for her 4 month wellness. On 26-JUL-2022, the patient was vaccinated with second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter/once, lot #1742079 with expiration date: 08-JUL-2022, administered orally for prophylaxis (strength was not provided); and second dose of diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL), lot: UJ50AA expiration date: 29-MAY-2022, intramuscularly (IM) on left thigh, administered for prophylaxis (strength, formulation, were not provided) (expired product administered). The patient's parent identified the event.   The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had no history of temperature excursions. Dose was supported by the post-expiry memo. The vaccine was available for return or evaluation. It was reported as single use vaccine. The operator of vaccine/was healthcare professional. The operator was trained. The vaccine had been disposed. The event had reported to doctor, health department and manufacturer. The vaccine was vaccinated at private doctor's office/hospital. The vaccine was purchased with private funds. There was no temperature excursion.   The patient did not have any adverse effects or symptoms following administration (no adverse event).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, Incorrect route of product administration, No adverse event
Clinical narrative: no reported side effects.; an expired dose of PROQUAD was administered to a patient; Subcutaneous injection formulation administered by other route; This spontaneous report was received from an office administrator referring to a 4-year-old unknown gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 27-JUL-2022, the patient was vaccinated with an expired dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA)) (PROQUAD) 0.5 mL x1 dose, lot #U002535, expiration date: 24-JUL-2022, intramuscularly (IM) for prophylaxis (strength was not provided) (incorrect route of product administration, expired product administered) which was reconstituted with sterile diluent (MERCK STERILE DILUENT) IM (lot # T029528, expiration date: 14-APR-2023) (dose, frequency, strength, formulation was not provided) which was not expired.  Reporter confirmed that the expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) had no temperature excursions. There was no adverse event reported and reported side effects (no adverse event).
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other issues or concerns noted.; Customer calling to report that PROQUAD and VARIVAX were administered at the same time.  No PQC.  No other information provided.  No other issues or concerns noted.  PROQUAD:  LOT: W007748 EXP: 7/4/2022 VARIVAX: LOT: U028164 EXP: 9/9/2023 ADMIN ON:; This spontaneous report was received from a medical assistant concerning to a 12-month-old patient with unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The reporter calling to report that on 25-JUL-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot # W007748, and expiration date: 04-SEP-2023, since it matched the autopopulated expiration date (strength and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U028164 and expiration date: 09-SEP-2023, since it matched the autopopulated expiration date (strength and route of administration were not provided) at the same time as a prophylaxis. No other information provided. No other issues or concerns noted.
Age: 33.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; Patient was administered the pediatric dose of VAQTA instead of the adult dose.; Dose: 25 units/0.5 mL; This spontaneous report as received from a licensed practical nurse refers to a 33-year-old patient of unknown gender.  Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 08-AUG-2022, the patient was vaccinated with the pediatric dose (25 units/0.5 mL) of hepatitis a vaccine, inactivated (VAQTA) (lot number: U024504, expiration date: 15-OCT-2022; route of administration not provided) instead of the adult dose (product administered to patient of inappropriate age, incorrect dosage administered). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD vaccine was administered to a patient after a temperature excursion      ?; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender.  There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.    On 09-AUG-2022, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL, lot # W006585, expiration date: 23-AUG-2023, albumin status has been verified as recombinant human albumin (rHA) (route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -13.2 degrees Celsius (C) for 4 hours (LLT: Product storage error temperature too low). There were no previous excursions reported. No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; A HCP called to report that a improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent (manufacturer unknown).  On 11-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml/once, lot #W003820, expiration date: 02-FEB-2024 (strength, and route of administration were not provided) administered for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in 6 degrees Fahrenheit (F) up to 14 F for 14 hours 10 minutes, and in 14 F up to 46 F (16.7F) for 5 hours 40 minutes (product storage error). There was no previous temperature excursion. No adverse effects reported.   This is one of two cases received from the same reporter; Sender's Comments:  US-009507513-2208USA006387:
Age: 0.5
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP reports the patient did not experience any side effects.; HCP called in to report that a 6 month old infant was administered GARDASIL 9 on 08/15/2022.; This spontaneous report as received from a registered nurse refers to a 6-month-old male patient.  Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 15-AUG-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) pre-filled syringe for prophylaxis (lot number: U032681, expiration date: 26-OCT-2023; dose, anatomical location, and route of administration not provided) (product administered to patient of inappropriate age). The patient did not experience any side effects (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient has had no known side effects; Medical Assistant called to report that an expired dose of ROTATEQ that was administered to a patient on 7/28/2022. The patient has had no known side effects. ROTATEQ expired on 7/18/2022; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUL-2022 , the patient was vaccinated expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #T040207, expiration date: 18-JUL-2022, administered for prophylaxis (strength, dose, dose number and route of administration were not provided) (expired product administered).  The patient had no known side effects.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No additional AE; Medical assistant calling reports 2 doses of expired PROQUAD were administered to 2 patients.; This spontaneous report has been received from a medical assistant, referring a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 18-MAY-2022 the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-Merck) virus vaccine live (recombinant human albumin rHA) (PROQUAD) (lot number T029102 has been verified to be a valid lot number, expiration date 23-FEB-2022) (strength, dose, frequency, route of administration, and anatomical location were not provided) as prophylaxis.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA006084:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical assistant reporting a temperature excursion for VARIVAX and states one dose has been administered on 8/15/2022; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 15-AUG-2022, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot # W003822 was confirmed to be valid, expiration date 02-FEB-2024, for prophylaxis (route of administration and anatomical site were not provided) (product storage error). The vaccine was improperly stored for 1 hour and 55 minutes in the temperature ranging from 6 degrees Fahrenheit (F) to 14 F (around 9.8 F). It was unknown if data logger was used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse event was reported (no adverse event).
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptomatic side effects; PROQUAD inadvertently given to a 14 year old; This spontaneous report was received from a nurse referring to a 14-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported.    On 15-AUG-2022, the patient was vaccinated inadvertently with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) which was reconstituted with sterile diluent (MERCK STERILE DILUENT).  No product confusion with the vaccine was registered as the healthcare professional (HCP) thought the patient was younger and within recommended age (product administered to patient of inappropriate age). No symptomatic side effects were reported.
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; An improperly stored dose of M-M-R II and VAQTA were administered to the patient on 24MAY2022 after experiencing a temperautre excursion.; This spontaneous report was received from a office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 24-MAY-2022, the patient was vaccinated with an improperly stored of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (lot # U033212 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported as 28-OCT-2022 and establish as 07-NOV-2022) and M-M-R II (lot # T033814 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 05-OCT-2022)  (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 54.4° Fahrenheit (F) for 11 hours respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 18 year old patient that received an adult dose of VAQTA instead of the pediatric dose; No additional adverse events; This spontaneous report was received from a medical assistant and refers to an 18-year-old male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #U013476, expiration date: 06-FEB-2022, administered for prophylaxis (strength, exact dose and route of administration were not provided) (product administered to patient of inappropriate age).  No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: No additional AE's and no PQC's were reported; patient missed his third dose of GARDASIL 9 according to the dosage schedule; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On unknown dates, the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, pre-filled syringe, for prophylaxis (exact dose, route of administration, anatomical site, lot # and expiry date were not provided). On 01-MAR-2021, the patient missed his third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) according to the dosage schedule (product dose omission issue). No additional adverse event was reported (no adverse event).