chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, VARCEL
Symptoms: Nasal injury, Rhinalgia, Syncope
Clinical narrative: After receiving vaccines client stood up so sister could receive hers. Client was instructed to sit down in the other chair, but before he sat down he fainted and landed on his right side. He regained consciousness right away. Client was place on cot with leg elevated and juice given. Upon examination he had bit his right upper lip, his right side of his head and his nose. Client had slight amount of blood coming from right nare. Ice pack placed behind client's neck and on client's nose. Juice was given. Client stated his nose was hurting and he thought it was broken. After 20 minutes on the client resting in supine position he sat up and stated his head hurt. Client's mother was instructed to bring client to the Urgent Care once they left to be evaluated. At 14:45 client stated he felt ok to leave. He slowly stood up and the nurse and his mother walked him to the car.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Lethargy, Pain, Pyrexia
Clinical narrative: Woke up approximately 13 hours after receiving first injection of Shingrix with severe flu-like symptoms.  Fever 101 degrees, uncontrollable chills with severe shaking,  lethargy.  Fever and chills subsided about 6 to 8 hours later although still noticeable present.   Other flu-like symptoms, lethargy, body aches, mild fever continued throughout the next day and night.   It took about 2.5 days to feel normal again after the injection.   Can't wait for round number 2....
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Woke up approximately 13 hours after receiving first injection of Shingrix with severe flu-like symptoms.  Fever 101 degrees, uncontrollable chills with severe shaking,  lethargy.  Fever and chills subsided about 6 to 8 hours later although still noticeable present.   Other flu-like symptoms, lethargy, body aches, mild fever continued throughout the next day and night.   It took about 2.5 days to feel normal again after the injection.   Can't wait for round number 2....
Age: 1.33
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Lymphadenopathy
Clinical narrative: Right inguinal lymphadenopathy discovered on 2/23/2020 during routine diaper change. Lump does not appear to be painful to patient, but concerned parents who brought her in.
Age: 1.42
Sex: M
Vaccine: HIBV, MMR
Symptoms: Asthenia, Eye movement disorder, Grunting, Influenza virus test negative, Opisthotonus
Clinical narrative: Patient developed tactile fever and decreased energy on 2/22/2020 per mother. Overnight, around 2 AM on 2/23/2020 mother heard grunting sound over baby monitor so she went to check on him. She found him with back arched and eyes rolling back. Episode lasted less than 30 seconds, and infant was "out of it" for a few minutes after the event. Parents took infant to Medical Center, where he was tested for flu, RSV (both negative) and monitored for additional seizures. He was discharged after about 4 hours. Infant came to pediatrician office on 2/24/2020 for follow up--still febrile (temperatures around 101 per report), parents using both tylenol and motrin at appropriate doses to control fever. No significant findings on exam.
Age: 1.42
Sex: M
Vaccine: HIBV, MMR
Symptoms: Pyrexia, Respiratory syncytial virus test negative, Seizure
Clinical narrative: Patient developed tactile fever and decreased energy on 2/22/2020 per mother. Overnight, around 2 AM on 2/23/2020 mother heard grunting sound over baby monitor so she went to check on him. She found him with back arched and eyes rolling back. Episode lasted less than 30 seconds, and infant was "out of it" for a few minutes after the event. Parents took infant to Medical Center, where he was tested for flu, RSV (both negative) and monitored for additional seizures. He was discharged after about 4 hours. Infant came to pediatrician office on 2/24/2020 for follow up--still febrile (temperatures around 101 per report), parents using both tylenol and motrin at appropriate doses to control fever. No significant findings on exam.
Age: 85.0
Sex: F
Vaccine: UNK
Symptoms: Influenza, Insomnia, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Pt had flu like symptoms as writer shared with daughter were normal. Pt had muscle pain. as writer shared with daughter were normal ** Per Daughter pt had Left arm pain that was excruiciating for 3 days and could not move limb nor sleep on limb ( wanted report filed)
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site nodule, Pain in extremity
Clinical narrative: Patient states his left arm is still painful from when  got flu shot on 10/10/2019. Says a knot has since developed from injection site.
Age: 54.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Unevaluable event
Clinical narrative: No
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: pt reported large swelling and redness around inection site, hot to touch and very painful for approx. 3 days. Tried ice and Ibuprofen with no resolve. I advised pt to contact md and seek medical attention. She went to the ER the next day and received steriods and antibiotic with possible cellulitis.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, X-ray limb
Clinical narrative: Adverse event: Left shoulder pain 1 week after injection administration.  Treatment: Physical therapy Outcome: Unknown
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site rash, Swelling, Vaccination site swelling
Clinical narrative: Localized swelling and erythema. Rash that developed along medial thigh. Swelling that extended from vaccine site to knee. Worsened x 48 hours, but today appears to be less red. No change in activity level.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Auditory disorder, Dizziness, Hypotension, Nausea
Clinical narrative: Patient reported dizziness, progressing to include feelings of weakness, nausea, and auditory disturbances. Patient was visibly pale. Patient was moved to a supine position. Palpable radial pulse was present when the patient was moved to the exam table. Patient reported complete recovery from apparent hypotensive episode in about 10 minutes and stated that she had felt some anxiety prior to the administration of the vaccine which she believed to have elevated her pulse even before the shot.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Pallor
Clinical narrative: Patient reported dizziness, progressing to include feelings of weakness, nausea, and auditory disturbances. Patient was visibly pale. Patient was moved to a supine position. Palpable radial pulse was present when the patient was moved to the exam table. Patient reported complete recovery from apparent hypotensive episode in about 10 minutes and stated that she had felt some anxiety prior to the administration of the vaccine which she believed to have elevated her pulse even before the shot.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient states she experienced redness, pain, and swelling in the left shoulder where the vaccines were administered as well as a fever.  She went to the local emergency room where a physician diagnosed her with cellulitis due to vaccine administration.  She was treated with a course of antibiotics.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Burning sensation, Cellulitis, Decreased appetite, Discomfort
Clinical narrative: vaccine created significant pain at time of injection.  2/1/20 patient felt uncomfortable, no appetite, tired and fever.  2/2/20 patient felt better. 2/3/20 arm was red and hot.  2/4/20  At 10am, arm was red and burning so made PCP appointment.  At 2pm appointment 1st noticed 5"x6" red raised area with 2"x3/4" blister.  Was diagnosed as cellulitis and treated with antibiotic, ibuprofen and undetermined cream per patient.  On 2/20/20 patient filled Medrol dosepack and silvadene cream to treat and reported treatment area was much improved
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Fatigue, Injection site pain, Pyrexia, Skin warm
Clinical narrative: vaccine created significant pain at time of injection.  2/1/20 patient felt uncomfortable, no appetite, tired and fever.  2/2/20 patient felt better. 2/3/20 arm was red and hot.  2/4/20  At 10am, arm was red and burning so made PCP appointment.  At 2pm appointment 1st noticed 5"x6" red raised area with 2"x3/4" blister.  Was diagnosed as cellulitis and treated with antibiotic, ibuprofen and undetermined cream per patient.  On 2/20/20 patient filled Medrol dosepack and silvadene cream to treat and reported treatment area was much improved
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: vaccine created significant pain at time of injection.  2/1/20 patient felt uncomfortable, no appetite, tired and fever.  2/2/20 patient felt better. 2/3/20 arm was red and hot.  2/4/20  At 10am, arm was red and burning so made PCP appointment.  At 2pm appointment 1st noticed 5"x6" red raised area with 2"x3/4" blister.  Was diagnosed as cellulitis and treated with antibiotic, ibuprofen and undetermined cream per patient.  On 2/20/20 patient filled Medrol dosepack and silvadene cream to treat and reported treatment area was much improved
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Tremor
Clinical narrative: Received the Shingrix (Shingles vaccine) and within 2-3 hours had extreme side effects. eg; headaches, spaciness, and violent shaking.
Sex: U
Vaccine: VARZOS
Symptoms: Product reconstitution quality issue
Clinical narrative: Shingrix vial for reconstitution did not have powder tablet within the vial. This is the second vial we have received like this.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Dyspnoea, Erythema, Fatigue, Headache
Clinical narrative: Received Pneumovax 23 vaccine, nurse informed she had never heard of side effects. Result: Sore, swollen. Day 2: Fever 100 deg, fatigue, nausea. Day 3: Arm turned red, dizziness. Day 4: Swollen glands, sore throat, headache. Day 5 & 6: Shortness of breath, sore throat, fatigue. Day 7: Back to normal. I was unable to go to work all that week.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Impaired work ability, Lymphadenopathy, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Received Pneumovax 23 vaccine, nurse informed she had never heard of side effects. Result: Sore, swollen. Day 2: Fever 100 deg, fatigue, nausea. Day 3: Arm turned red, dizziness. Day 4: Swollen glands, sore throat, headache. Day 5 & 6: Shortness of breath, sore throat, fatigue. Day 7: Back to normal. I was unable to go to work all that week.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Received Pneumovax 23 vaccine, nurse informed she had never heard of side effects. Result: Sore, swollen. Day 2: Fever 100 deg, fatigue, nausea. Day 3: Arm turned red, dizziness. Day 4: Swollen glands, sore throat, headache. Day 5 & 6: Shortness of breath, sore throat, fatigue. Day 7: Back to normal. I was unable to go to work all that week.
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Decreased appetite, Dizziness, Headache, Injection site erythema
Clinical narrative: After getting the Pneumovax 23 vaccine, the injection became red swollen hard and painful. Also feel low energy, headache, dizzy, cold and small appetite.
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Nasopharyngitis
Clinical narrative: After getting the Pneumovax 23 vaccine, the injection became red swollen hard and painful. Also feel low energy, headache, dizzy, cold and small appetite.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: 12year old boy had gardasil at school and developed a wart on the 2nd toe of the right foot.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient complaining of arm and shoulder pain a week after the immunization. Patient say pharmacist hand slipped off syringe and he was punched in the arm.
Age: 40.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Headache
Clinical narrative: Continuous headache for one month-
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Dizziness, Headache, Influenza virus test negative, Injection site reaction
Clinical narrative: My 8-yo son received a second vaccine for the Pneumovax 23 from his allergist/immunologist on 2/4/2020. He initially had a local site reaction. Beginning the next day he began to have severe body pain and high fever with the site reaction spreading. On Wednesday, I was unable to control his fever, and went to the ER with a temp of 104.9. He had lightheadedness, headache, body pain, and the site reaction along with severe pain in his arm. They diagnosed as Cellulitis; as his flu swab came back negative and prescribed antibiotics as a prescautionary measure. I took him to his PCP who stated they believe it was a severe reaction due to the vaccine. In the research I have been able to find, the only site that listed any severe symptoms and/or reactions were on the website which identifies: Adverse reactions to Pneumovax 23 Pneumovax 23 vaccine is known to be associated with a high rate of local injection site reactions. The majority of these are mild, with redness, swelling, pain and a feeling of heat around the site where the injection was given and recovery within a couple of days. Some reactions can result in extensive swelling and pain that can limit the use of the arm. Cellulitis-like reactions and abscesses can also occur. Injection site reactions are very common but very severe reactions such as cellulitis-like reactions and abscesses are rare. More information about possible adverse reactions is available in the Pneumovax 23 Product Information (PI), which has recently been revised. I believe he had the cellulitis-like reaction as he is beginning to get relief from steroid and anti-inflammatory medications. While the muscle pain in his arm is still there, the site reaction continued to spread until the steroid was prescribed.
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Vaccination complication
Clinical narrative: My 8-yo son received a second vaccine for the Pneumovax 23 from his allergist/immunologist on 2/4/2020. He initially had a local site reaction. Beginning the next day he began to have severe body pain and high fever with the site reaction spreading. On Wednesday, I was unable to control his fever, and went to the ER with a temp of 104.9. He had lightheadedness, headache, body pain, and the site reaction along with severe pain in his arm. They diagnosed as Cellulitis; as his flu swab came back negative and prescribed antibiotics as a prescautionary measure. I took him to his PCP who stated they believe it was a severe reaction due to the vaccine. In the research I have been able to find, the only site that listed any severe symptoms and/or reactions were on the website which identifies: Adverse reactions to Pneumovax 23 Pneumovax 23 vaccine is known to be associated with a high rate of local injection site reactions. The majority of these are mild, with redness, swelling, pain and a feeling of heat around the site where the injection was given and recovery within a couple of days. Some reactions can result in extensive swelling and pain that can limit the use of the arm. Cellulitis-like reactions and abscesses can also occur. Injection site reactions are very common but very severe reactions such as cellulitis-like reactions and abscesses are rare. More information about possible adverse reactions is available in the Pneumovax 23 Product Information (PI), which has recently been revised. I believe he had the cellulitis-like reaction as he is beginning to get relief from steroid and anti-inflammatory medications. While the muscle pain in his arm is still there, the site reaction continued to spread until the steroid was prescribed.
Age: 1.75
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse reaction. Reporting using VAERS to report incorrect vaccine administered. No Adverse reaction occurred after the administration of the incorrect vaccine, DTaP-Hib-IPV. vaccine was given. VAERS reported only to acknowledge the clinic's mistake. Patient was due for Dtap only, IPV + Hib were already up to date per immunization record.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Gastrointestinal disorder, Headache, Heart rate increased
Clinical narrative: INTENSE SHIVERING X 3HRS HEADACHE POSSIBLE FEVER ELEVATED PULSE AROUND 100 (MY NORMAL 70'S) COULD NOT GET WARM GI SYMPTOMS
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Allergic reaction & redness, swelling and itchness on left upper arm. no pain or fever.  Treatment: Antihistamine ; Motrin Outcome: will follow up
Age: 26.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Abdominal pain upper, Headache, Muscular weakness, Nausea, Vomiting
Clinical narrative: 1/29/20 - After vaccine stomach ache, headache, muscle weakness  2/5/20 - After vaccine stomach ache, nausea, vomiting, headache, muscle weakness.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Dysphagia, Laryngitis, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: Throat felt sore, then swelled, produced lots of phlegm, hard to swallow, tightening of throat. Was given prescriptions! Methylprednisolone Z-pac Took 2 weeks to recover voice Temp. 100.5 - Hard to talk - sounded like laryngitis when I spoke.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Productive cough, Throat tightness
Clinical narrative: Throat felt sore, then swelled, produced lots of phlegm, hard to swallow, tightening of throat. Was given prescriptions! Methylprednisolone Z-pac Took 2 weeks to recover voice Temp. 100.5 - Hard to talk - sounded like laryngitis when I spoke.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Urticaria
Clinical narrative: Developed hives on left arm on 2/21/2020 they went away and came back on 2/22/20202 in the evening, only on left arm then have dissipated w/no intervention
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Peripheral swelling, Rash papular
Clinical narrative: Pt received pentacel and within 5 hours developed papular rash in deltoid along with swelling of hands + feet (B). No SOB No wheeze. Pt with normal hands + feet on exam next day.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Cold sweat, Fatigue, Pain
Clinical narrative: Patient started feeling severe fatigue and stomach pain within 4 hours of receiving vaccine, proceeded to vomit 3 times and develop low grade fever (99.6) and body aches/chills. Most of the symptoms resolved within 3 days, however severe fatigue and cold sweats lasted 7 days. After 7 days, all side effects resolved.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient started feeling severe fatigue and stomach pain within 4 hours of receiving vaccine, proceeded to vomit 3 times and develop low grade fever (99.6) and body aches/chills. Most of the symptoms resolved within 3 days, however severe fatigue and cold sweats lasted 7 days. After 7 days, all side effects resolved.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Alopecia, Angiogram, Biopsy bone marrow, C-reactive protein increased, Computerised tomogram
Clinical narrative: gastrointestinal problems secondary to Postural Orthostatic Tachycardia Syndrome (POTS); She has an elevated SED rate and CRP, indicating autoimmune disorder.; fever-like symptoms/ She has since developed Postural Orthostatic Tachycardia Syndrome (POTS) and she struggled with rapid changes in her heart rate.; This spontaneous report as received from the patient's mother refers to a 16-year-old female patient without drug allergies. The current conditions included asthma, eczema and peanut allergy. The patient did not take any concomitant medications. On unknown date in July 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (exact dose, lot# and expiration date were not reported) for prevention. On 21-SEP-2019 (reported also as about two months later), the patient experienced fever-like symptoms and since then developed postural orthostatic tachycardia syndrome (POTS) and she struggled with rapid changes in her heart rate. On an unknown date, the patient had an elevated Sedimentation (SED) rate and C-Reactive Protein Test (CRP), which indicated autoimmune disorder. At the time of the report, the patient was home-bound from school, experienced severe fatigue, an abnormal heart rate, fainting (POTS symptoms), and also gastrointestinal problems secondary to POTS. The patient was hospitalized for the adverse events on an unknown date. Multiple tests were performed: routine lab work to rule out infectious disease, bone scan, Magnetic Resonance Imaging (MRI)/Magnetic Resonance Angiography (MRA), abdominal ultrasounds, bone marrow biopsy but the results were not provided. Unspecified treatment for adverse events was given. Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.   The outcome of fever-like symptoms, postural orthostatic tachycardia syndrome, autoimmune disorder and gastrointestinal problems secondary to POTS was reported as not recovered/not resolved.  The causality assessment between the events and the suspect therapy was not provided.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fatigue, Heart rate abnormal, Housebound, Impaired gastric emptying, Magnetic resonance imaging
Clinical narrative: gastrointestinal problems secondary to Postural Orthostatic Tachycardia Syndrome (POTS); She has an elevated SED rate and CRP, indicating autoimmune disorder.; fever-like symptoms/ She has since developed Postural Orthostatic Tachycardia Syndrome (POTS) and she struggled with rapid changes in her heart rate.; This spontaneous report as received from the patient's mother refers to a 16-year-old female patient without drug allergies. The current conditions included asthma, eczema and peanut allergy. The patient did not take any concomitant medications. On unknown date in July 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (exact dose, lot# and expiration date were not reported) for prevention. On 21-SEP-2019 (reported also as about two months later), the patient experienced fever-like symptoms and since then developed postural orthostatic tachycardia syndrome (POTS) and she struggled with rapid changes in her heart rate. On an unknown date, the patient had an elevated Sedimentation (SED) rate and C-Reactive Protein Test (CRP), which indicated autoimmune disorder. At the time of the report, the patient was home-bound from school, experienced severe fatigue, an abnormal heart rate, fainting (POTS symptoms), and also gastrointestinal problems secondary to POTS. The patient was hospitalized for the adverse events on an unknown date. Multiple tests were performed: routine lab work to rule out infectious disease, bone scan, Magnetic Resonance Imaging (MRI)/Magnetic Resonance Angiography (MRA), abdominal ultrasounds, bone marrow biopsy but the results were not provided. Unspecified treatment for adverse events was given. Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.   The outcome of fever-like symptoms, postural orthostatic tachycardia syndrome, autoimmune disorder and gastrointestinal problems secondary to POTS was reported as not recovered/not resolved.  The causality assessment between the events and the suspect therapy was not provided.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Nausea, Postural orthostatic tachycardia syndrome, Pyrexia, Red blood cell sedimentation rate increased, Syncope
Clinical narrative: gastrointestinal problems secondary to Postural Orthostatic Tachycardia Syndrome (POTS); She has an elevated SED rate and CRP, indicating autoimmune disorder.; fever-like symptoms/ She has since developed Postural Orthostatic Tachycardia Syndrome (POTS) and she struggled with rapid changes in her heart rate.; This spontaneous report as received from the patient's mother refers to a 16-year-old female patient without drug allergies. The current conditions included asthma, eczema and peanut allergy. The patient did not take any concomitant medications. On unknown date in July 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (exact dose, lot# and expiration date were not reported) for prevention. On 21-SEP-2019 (reported also as about two months later), the patient experienced fever-like symptoms and since then developed postural orthostatic tachycardia syndrome (POTS) and she struggled with rapid changes in her heart rate. On an unknown date, the patient had an elevated Sedimentation (SED) rate and C-Reactive Protein Test (CRP), which indicated autoimmune disorder. At the time of the report, the patient was home-bound from school, experienced severe fatigue, an abnormal heart rate, fainting (POTS symptoms), and also gastrointestinal problems secondary to POTS. The patient was hospitalized for the adverse events on an unknown date. Multiple tests were performed: routine lab work to rule out infectious disease, bone scan, Magnetic Resonance Imaging (MRI)/Magnetic Resonance Angiography (MRA), abdominal ultrasounds, bone marrow biopsy but the results were not provided. Unspecified treatment for adverse events was given. Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.   The outcome of fever-like symptoms, postural orthostatic tachycardia syndrome, autoimmune disorder and gastrointestinal problems secondary to POTS was reported as not recovered/not resolved.  The causality assessment between the events and the suspect therapy was not provided.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Vomiting
Clinical narrative: gastrointestinal problems secondary to Postural Orthostatic Tachycardia Syndrome (POTS); She has an elevated SED rate and CRP, indicating autoimmune disorder.; fever-like symptoms/ She has since developed Postural Orthostatic Tachycardia Syndrome (POTS) and she struggled with rapid changes in her heart rate.; This spontaneous report as received from the patient's mother refers to a 16-year-old female patient without drug allergies. The current conditions included asthma, eczema and peanut allergy. The patient did not take any concomitant medications. On unknown date in July 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (exact dose, lot# and expiration date were not reported) for prevention. On 21-SEP-2019 (reported also as about two months later), the patient experienced fever-like symptoms and since then developed postural orthostatic tachycardia syndrome (POTS) and she struggled with rapid changes in her heart rate. On an unknown date, the patient had an elevated Sedimentation (SED) rate and C-Reactive Protein Test (CRP), which indicated autoimmune disorder. At the time of the report, the patient was home-bound from school, experienced severe fatigue, an abnormal heart rate, fainting (POTS symptoms), and also gastrointestinal problems secondary to POTS. The patient was hospitalized for the adverse events on an unknown date. Multiple tests were performed: routine lab work to rule out infectious disease, bone scan, Magnetic Resonance Imaging (MRI)/Magnetic Resonance Angiography (MRA), abdominal ultrasounds, bone marrow biopsy but the results were not provided. Unspecified treatment for adverse events was given. Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.   The outcome of fever-like symptoms, postural orthostatic tachycardia syndrome, autoimmune disorder and gastrointestinal problems secondary to POTS was reported as not recovered/not resolved.  The causality assessment between the events and the suspect therapy was not provided.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Angiogram, Autoimmune disorder, Biopsy bone marrow, Bone scan, C-reactive protein increased
Clinical narrative: gastrointestinal problems secondary to Postural Orthostatic Tachycardia Syndrome (POTS); She has an elevated SED rate and CRP, indicating autoimmune disorder.; fever-like symptoms/ She has since developed Postural Orthostatic Tachycardia Syndrome (POTS) and she struggled with rapid changes in her heart rate.; This spontaneous report as received from the patient's mother refers to a 16-year-old female patient without drug allergies. The current conditions included asthma, eczema and peanut allergy. The patient did not take any concomitant medications. On unknown date in July 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (exact dose, lot# and expiration date were not reported) for prevention. On 21-SEP-2019 (reported also as about two months later), the patient experienced fever-like symptoms and since then developed postural orthostatic tachycardia syndrome (POTS) and she struggled with rapid changes in her heart rate. On an unknown date, the patient had an elevated Sedimentation (SED) rate and C-Reactive Protein Test (CRP), which indicated autoimmune disorder. At the time of the report, the patient was home-bound from school, experienced severe fatigue, an abnormal heart rate, fainting (POTS symptoms), and also gastrointestinal problems secondary to POTS. The patient was hospitalized for the adverse events on an unknown date. Multiple tests were performed: routine lab work to rule out infectious disease, bone scan, Magnetic Resonance Imaging (MRI)/Magnetic Resonance Angiography (MRA), abdominal ultrasounds, bone marrow biopsy but the results were not provided. Unspecified treatment for adverse events was given. Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.   The outcome of fever-like symptoms, postural orthostatic tachycardia syndrome, autoimmune disorder and gastrointestinal problems secondary to POTS was reported as not recovered/not resolved.  The causality assessment between the events and the suspect therapy was not provided.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fatigue, Gastrointestinal disorder, Heart rate abnormal, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: gastrointestinal problems secondary to Postural Orthostatic Tachycardia Syndrome (POTS); She has an elevated SED rate and CRP, indicating autoimmune disorder.; fever-like symptoms/ She has since developed Postural Orthostatic Tachycardia Syndrome (POTS) and she struggled with rapid changes in her heart rate.; This spontaneous report as received from the patient's mother refers to a 16-year-old female patient without drug allergies. The current conditions included asthma, eczema and peanut allergy. The patient did not take any concomitant medications. On unknown date in July 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (exact dose, lot# and expiration date were not reported) for prevention. On 21-SEP-2019 (reported also as about two months later), the patient experienced fever-like symptoms and since then developed postural orthostatic tachycardia syndrome (POTS) and she struggled with rapid changes in her heart rate. On an unknown date, the patient had an elevated Sedimentation (SED) rate and C-Reactive Protein Test (CRP), which indicated autoimmune disorder. At the time of the report, the patient was home-bound from school, experienced severe fatigue, an abnormal heart rate, fainting (POTS symptoms), and also gastrointestinal problems secondary to POTS. The patient was hospitalized for the adverse events on an unknown date. Multiple tests were performed: routine lab work to rule out infectious disease, bone scan, Magnetic Resonance Imaging (MRI)/Magnetic Resonance Angiography (MRA), abdominal ultrasounds, bone marrow biopsy but the results were not provided. Unspecified treatment for adverse events was given. Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.   The outcome of fever-like symptoms, postural orthostatic tachycardia syndrome, autoimmune disorder and gastrointestinal problems secondary to POTS was reported as not recovered/not resolved.  The causality assessment between the events and the suspect therapy was not provided.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Magnetic resonance imaging, Postural orthostatic tachycardia syndrome, Pyrexia, Red blood cell sedimentation rate increased, Syncope
Clinical narrative: gastrointestinal problems secondary to Postural Orthostatic Tachycardia Syndrome (POTS); She has an elevated SED rate and CRP, indicating autoimmune disorder.; fever-like symptoms/ She has since developed Postural Orthostatic Tachycardia Syndrome (POTS) and she struggled with rapid changes in her heart rate.; This spontaneous report as received from the patient's mother refers to a 16-year-old female patient without drug allergies. The current conditions included asthma, eczema and peanut allergy. The patient did not take any concomitant medications. On unknown date in July 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (exact dose, lot# and expiration date were not reported) for prevention. On 21-SEP-2019 (reported also as about two months later), the patient experienced fever-like symptoms and since then developed postural orthostatic tachycardia syndrome (POTS) and she struggled with rapid changes in her heart rate. On an unknown date, the patient had an elevated Sedimentation (SED) rate and C-Reactive Protein Test (CRP), which indicated autoimmune disorder. At the time of the report, the patient was home-bound from school, experienced severe fatigue, an abnormal heart rate, fainting (POTS symptoms), and also gastrointestinal problems secondary to POTS. The patient was hospitalized for the adverse events on an unknown date. Multiple tests were performed: routine lab work to rule out infectious disease, bone scan, Magnetic Resonance Imaging (MRI)/Magnetic Resonance Angiography (MRA), abdominal ultrasounds, bone marrow biopsy but the results were not provided. Unspecified treatment for adverse events was given. Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.   The outcome of fever-like symptoms, postural orthostatic tachycardia syndrome, autoimmune disorder and gastrointestinal problems secondary to POTS was reported as not recovered/not resolved.  The causality assessment between the events and the suspect therapy was not provided.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Ultrasound abdomen
Clinical narrative: gastrointestinal problems secondary to Postural Orthostatic Tachycardia Syndrome (POTS); She has an elevated SED rate and CRP, indicating autoimmune disorder.; fever-like symptoms/ She has since developed Postural Orthostatic Tachycardia Syndrome (POTS) and she struggled with rapid changes in her heart rate.; This spontaneous report as received from the patient's mother refers to a 16-year-old female patient without drug allergies. The current conditions included asthma, eczema and peanut allergy. The patient did not take any concomitant medications. On unknown date in July 2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (exact dose, lot# and expiration date were not reported) for prevention. On 21-SEP-2019 (reported also as about two months later), the patient experienced fever-like symptoms and since then developed postural orthostatic tachycardia syndrome (POTS) and she struggled with rapid changes in her heart rate. On an unknown date, the patient had an elevated Sedimentation (SED) rate and C-Reactive Protein Test (CRP), which indicated autoimmune disorder. At the time of the report, the patient was home-bound from school, experienced severe fatigue, an abnormal heart rate, fainting (POTS symptoms), and also gastrointestinal problems secondary to POTS. The patient was hospitalized for the adverse events on an unknown date. Multiple tests were performed: routine lab work to rule out infectious disease, bone scan, Magnetic Resonance Imaging (MRI)/Magnetic Resonance Angiography (MRA), abdominal ultrasounds, bone marrow biopsy but the results were not provided. Unspecified treatment for adverse events was given. Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.   The outcome of fever-like symptoms, postural orthostatic tachycardia syndrome, autoimmune disorder and gastrointestinal problems secondary to POTS was reported as not recovered/not resolved.  The causality assessment between the events and the suspect therapy was not provided.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Abnormal behaviour, Generalised tonic-clonic seizure, Speech disorder
Clinical narrative: 1 hour after the vaccine, patient became disconnected.  His speech was unintelligible and words didn't make sense to the situation.  His behavior was erratic and beyond wild for his age.  In the morning after the vaccine patient had a tonic clonic seizure that led into a nonconvulsive seizure. this lasted approximately 4-5 minutes
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Dysphonia, Swelling, Throat irritation
Clinical narrative: Feeling of swollen, scratchy throat with hoarse voice starting one hour after injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Feeling abnormal, Headache
Clinical narrative: I felt terrible.  headache, sick in stomach, pretty much all of the listed side effects
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: painful swelling of the upper arm down to below the elbow; painful swelling of the upper arm down to below the elbow impacting mobility; painful swelling of the upper arm down to below the elbow; This spontaneous report was received from a consumer via a company representative and refers to a female patient of unknown age. There was no information about her concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, she experienced painful swelling of the upper arm down to below the elbow impacting mobility.   The outcome of the events and the relatedness between the events and the suspect vaccine were not provided.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; patient received improperly stored vaccine which was administered via unspecified route; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 05-FEB-2020, the patient received improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) which was administered via unspecified route,  lot # S033516 (verified to be a valid lot number), expiration date reported and established as 29-JUN-2021, for prophylaxis. The call was because of a data logger and no additional adverse event was reported. The vaccine was improperly stored during a time frame of 15 minutes and highest temperature above 47°F/9°C 47.6°F. The following was the previous temperature excursions reported: temperature total time and highest temperature above 47°F/9°C 52.5°F, time frame 15 minutes, temperature total time and highest temperature above 47°F/9°C 46.7°F, time frame 15 minutes, temperature total time and highest temperature above 47°F/9°C 47.1°F, time frame 15 minutes.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms being reported.; Patient who is 21 years old, inadvertently received a (second) dose of PROQUAD/patient also received first dose of PROQUAD on 08/07/2019 (21 years old); This spontaneous report was received from a nurse, referring to a 20-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not reported.  On 07-AUG-2019, at the age of 20, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 1 dosage form, for prophylaxis (product use issue) (albumin status, concentration, frequency of vaccination scheme, route and anatomical location of vaccination, lot number and expiry date were not reported).   On 10-FEB-2020, at the age of 21, the patient was inadvertently vaccinated with a second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant human albumin) (PROQUAD) (lot number S012534 had been verified to be a valid number; expiration date reported and validated as 20-OCT-2020) (product use issue) ( concentration, frequency of vaccination scheme, route and anatomical location of vaccination, were not reported).  No symptoms were reported (no adverse event).  The reporter did not have available information about the diluent used.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: A patient was administered an improperly stored PROQUAD.; No additional adverse events.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not reported.  On 20-FEB-2020, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant human albumin) (PROQUAD) (product storage error) for prophylaxis (lot number S027459 has been verified to be a valid lot number, expiration date reported and validated as 02-MAR-2021) (concentration, dose, dose number, frequency of vaccination scheme, route and anatomical location of vaccination were not reported).   It was also reported that the sterile diluent used to reconstitute the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant human albumin) (PROQUAD) was properly stored.   No additional adverse event was reported.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: no adverse event; daughter was administered GARDASIL 9 on 27-MAR-2019 after was administered GRADASIL 9 on 09-JUN-2017; This spontaneous report was received from a registered nurse, referring to her 14 year old daughter. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 09-JUN-2017, when the patient was 12 years old, she was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 27-MAR-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). No adverse events were reported.
Sex: F
Vaccine: HEPA, MMR
Symptoms: Death, General physical health deterioration, Organ failure, Renal failure
Clinical narrative: RENAL FAILURE; ORGAN FAILURE; Deterioated quickly; This spontaneous report was received from a nurse via company representative refers to a 40 year old female patient (nurse's cousin). The patient's concurrent condition included pulmonary hypertension. The patient's medical history, concomitant medication, drug reactions and allergies were not reported. It was reported that the patient was awaiting for a heart and double lung transplant. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and hepatitis a vaccine, inactivated (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot# and expiration date was not reported for both the suspect therapies) for prophylaxis. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, dose, indication, route of administration, lot# and expiration date was not reported). On an unknown date after receiving the vaccines, the patient experienced quick deterioration and went into organ and renal failure (organ failure, general physical health deterioration and renal failure). On 10-FEB-2020, the patient died. It was unknown if an autopsy was performed. The cause of death was not reported. Causality was not reported. No product quality complaint (PQC) was involved with this report.  Upon internal review, the event of renal failure was determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: she received the second dose of gardasil 9 14 months later; This spontaneous report was received from a physician, refers to a 15 year old female patient. Information regarding patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiry date, dose, frequency, route of administration and anatomical location were not reported) first dose for prophylaxis. On an unknown date (reported as 14 months later), the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). The physician wanted to know, if the patient needed to start the series over. The outcome of the event was unknown.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse effects; an administered dose of VAQTA underwent a temperature excursion on 02/19/2020 prior to being administered to 1 patient on 02/20/2020; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.     On 19-FEB-2020, an administered dose of hepatitis A vaccine, inactivated (VAQTA) underwent a temperature excursion prior to being administered. On 20-FEB-2020, the patient was vaccinated with the dose of hepatitis A vaccine, inactivated (VAQTA) (lot number S025993, expiration date 17-OCT-2020; route, strength and frequency unknown) for prophylaxis (incorrect product storage).  The storage temperature of the vaccine was 10 degree Celsius for a time frame of 2 minutes. There was no previous temperature excursion. The call was because of a data logger. No known adverse effects were reported.