chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 month old child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 17-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours for 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009326: Original Case : 1902USA009323.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 year old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 26-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 26-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 month old child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 21-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009326: Original Case : 1902USA009323.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 20-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old Child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 20-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009326:Original Case : 1902USA009323.
Age: 51.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Back pain, Chest pain, Decreased appetite, Erythema, Injection site erythema
Clinical narrative: Fever, pain, redness, heat, and rash extending across chest, back, and upper arm, from shoulder to elbow with edema, decreased appetite, general malaise.
Age: 51.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Injection site oedema, Injection site pain, Injection site rash, Injection site warmth, Malaise
Clinical narrative: Fever, pain, redness, heat, and rash extending across chest, back, and upper arm, from shoulder to elbow with edema, decreased appetite, general malaise.
Age: 51.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Pain, Pyrexia, Rash, Skin warm
Clinical narrative: Fever, pain, redness, heat, and rash extending across chest, back, and upper arm, from shoulder to elbow with edema, decreased appetite, general malaise.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Confusional state, Eye pain, Headache
Clinical narrative: Feb 11 - Had vaccine, had not been ill in months. Feb 12 - Passed out in the bathroom when I got up that morning. Low blood pressure. Feb 15 - Sudden onset headache with visual disturbance. Left thumb and forefinger went completely numb for a few minutes. Entire episode lasted about 30 minutes. Feb 17 - Another sudden headache with some visual disturbance. Feb 19 - Sudden intense headache, visual disturbance, confusion, speech problem, pain behind left eye. Did not let up. After 2 hours, went to ER, stayed overnight to determine if stroke symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Hypotension, Loss of consciousness, Nuclear magnetic resonance imaging brain, Speech disorder
Clinical narrative: Feb 11 - Had vaccine, had not been ill in months. Feb 12 - Passed out in the bathroom when I got up that morning. Low blood pressure. Feb 15 - Sudden onset headache with visual disturbance. Left thumb and forefinger went completely numb for a few minutes. Entire episode lasted about 30 minutes. Feb 17 - Another sudden headache with some visual disturbance. Feb 19 - Sudden intense headache, visual disturbance, confusion, speech problem, pain behind left eye. Did not let up. After 2 hours, went to ER, stayed overnight to determine if stroke symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Feb 11 - Had vaccine, had not been ill in months. Feb 12 - Passed out in the bathroom when I got up that morning. Low blood pressure. Feb 15 - Sudden onset headache with visual disturbance. Left thumb and forefinger went completely numb for a few minutes. Entire episode lasted about 30 minutes. Feb 17 - Another sudden headache with some visual disturbance. Feb 19 - Sudden intense headache, visual disturbance, confusion, speech problem, pain behind left eye. Did not let up. After 2 hours, went to ER, stayed overnight to determine if stroke symptoms.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Pain in extremity, Vomiting
Clinical narrative: Sore Arm. Aches, chills and a throbbing headache X 5 days. Vomiting on one occasion and then horrible stomach pain for 4 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Musculoskeletal pain, Pain in extremity, Rash
Clinical narrative: Pt states redness and bumps on upper arm, axilla, and shoulder which appeared on 2/23/19 and have steadily cleared since that time. Pt also cites mild pain and soreness of upper arm, axilla, and shoulder.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Blood test, Developmental regression, Electroencephalogram, Lymphadenopathy, Nervous system disorder
Clinical narrative: Previously noticed tics and twitches after Dtap#1&2. Dtap#1 was given by doctor before recommended age without full informed consent to parents. It was administered at 4 weeks adjusted age to premature baby. Neurological regression after 3rd shot. Seizures and developmental regression. Also onset lymphadenopathy diagnosed.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Seizure
Clinical narrative: Previously noticed tics and twitches after Dtap#1&2. Dtap#1 was given by doctor before recommended age without full informed consent to parents. It was administered at 4 weeks adjusted age to premature baby. Neurological regression after 3rd shot. Seizures and developmental regression. Also onset lymphadenopathy diagnosed.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza, Injection site rash, Malaise, Pain in extremity
Clinical narrative: Flu symptoms severe two days then fatigue, malaise on-going on day 4. Arm swelling pain and itching on-going day 4. Rash spreading currently 6inches by 10 inches around injection site.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Flu symptoms severe two days then fatigue, malaise on-going on day 4. Arm swelling pain and itching on-going day 4. Rash spreading currently 6inches by 10 inches around injection site.
Age: 34.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Dizziness, Hyperhidrosis, Nausea, Paraesthesia, Posture abnormal
Clinical narrative: Patient received BOOSTRIX first, then FLUZONE second. Within 1 minute of flu shot, pt stated that she felt dizzy and then listed over, but rph was able to support her while seated. She managed a sip of water from a water bottle, stated she was still dizzy and nauseous, and laid down on the floor. Patient showed signs of rapid breathing, reported nausea, sweats, and tingling feeling in arms (like vasovagal syncope). Symptoms didn't abate, 911 called. She threw up (minimal and saliva-like) and stated that she had not eaten anything yet that day. 911 ambulance arrived and monitored pt vitals, tried to regulate patient breathing, but with no improvement after 15 minutes, was taken to ER/hospital.
Age: 34.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Respiratory rate increased, Syncope, Vomiting
Clinical narrative: Patient received BOOSTRIX first, then FLUZONE second. Within 1 minute of flu shot, pt stated that she felt dizzy and then listed over, but rph was able to support her while seated. She managed a sip of water from a water bottle, stated she was still dizzy and nauseous, and laid down on the floor. Patient showed signs of rapid breathing, reported nausea, sweats, and tingling feeling in arms (like vasovagal syncope). Symptoms didn't abate, 911 called. She threw up (minimal and saliva-like) and stated that she had not eaten anything yet that day. 911 ambulance arrived and monitored pt vitals, tried to regulate patient breathing, but with no improvement after 15 minutes, was taken to ER/hospital.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash
Clinical narrative: Her arm had a swollen rash down to the elbow.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Pain
Clinical narrative: Cold-like symptoms, achy.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Presyncope
Clinical narrative: Patient first received MENACTRA in right arm without issues, placed tdap in left arm when patient had a vasovagul response and passed out. Mom laid patient down on exam table and patient gain conscious after a few seconds. Patient was pale and diaphoretic. Elevated patients legs. Took BP 82/52. Had patient drink apple juice while laying down. Took BP again 6:23 pm 60/60. 6:25 PM patient sat up on exam table, BP 102/62. 6:35 pm patient was able to ambulate out of clinic with mom, without any complaints of dizziness or lightheadedness.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Shoulder pain that has not gone away since the day after injection. Reduced range of motion in left shoulder, difficulty lifting arm. Pain radiating up to neck from injection site.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Decreased appetite, Dizziness, Lethargy, Pyrexia, Syncope
Clinical narrative: Patient's 1st dose was in December. He had mild fevers. Loss of appetite, and was lethargic for the following 4 days. His 2nd dose was today and he became dizzy and fainted. He was monitored for about 20 minutes afterwards because his vitals dropped as well. He's doing better but I'm worried about his 3rd dose and whether he should have it. The HPV vaccine does not bode well with him.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Emotional distress, Feeling abnormal, Flushing, Hypersomnia, Injection site erythema
Clinical narrative: Sleepy within 2 hours of injections. Slept longer than normal for nap. Flushed cheeks around 4 PM,  fever about same time. Inconsolable for bedtime. Didnt want to nurse. Injection site a little red. Fever stayed at least 100.1 on next day 02/21/19. She was whiny as of she didnt feel good. In injection site super red and big on left thigh. 02/22/19 no fever finally. She hardly nursed. By noon she would have nursed like 3-4 times and she had only nursed once. She was like that all day. Also whiny again, as if she didnt feel good. Injection site still red and big. 02/23/19 injection site not red but a lump under skin. 02/25/19 lump still under skin at injection site.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site mass, Irritability, Pyrexia, Somnolence
Clinical narrative: Sleepy within 2 hours of injections. Slept longer than normal for nap. Flushed cheeks around 4 PM,  fever about same time. Inconsolable for bedtime. Didnt want to nurse. Injection site a little red. Fever stayed at least 100.1 on next day 02/21/19. She was whiny as of she didnt feel good. In injection site super red and big on left thigh. 02/22/19 no fever finally. She hardly nursed. By noon she would have nursed like 3-4 times and she had only nursed once. She was like that all day. Also whiny again, as if she didnt feel good. Injection site still red and big. 02/23/19 injection site not red but a lump under skin. 02/25/19 lump still under skin at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Impaired work ability, Inflammation, Peripheral swelling
Clinical narrative: Pt states her arm was red and swollen the day after SHINGRIX was given. She watched her arm for a couple days and it continued to get more inflamed. She developed a fever and went to walk in clinic to see a CRNP. CRNP stated Patienthad cellulitis and was given an antibiotic and work excuse.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt states her arm was red and swollen the day after SHINGRIX was given. She watched her arm for a couple days and it continued to get more inflamed. She developed a fever and went to walk in clinic to see a CRNP. CRNP stated Patienthad cellulitis and was given an antibiotic and work excuse.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: By 7 AM after vaccination date, arm extremely sore, with large red swelling around injection site (about 1.5 inches wide vertically, two inches high horizontally, and raised a few millimeters). Low-grade fever, chills. Treated with ibuprofen with some relief. But now, 6 PM, fever returning, and experiencing facial swelling.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: By 7 AM after vaccination date, arm extremely sore, with large red swelling around injection site (about 1.5 inches wide vertically, two inches high horizontally, and raised a few millimeters). Low-grade fever, chills. Treated with ibuprofen with some relief. But now, 6 PM, fever returning, and experiencing facial swelling.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Pain
Clinical narrative: Saturday - pain at injection site. Saturday evening - shivering, aching joints. Sunday - achy, tired, beginning of swollen armpit region (gland?). Monday - swollen armpit region. Tuesday - attempted to follow up with patient, but unable to reach him.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Saturday - pain at injection site. Saturday evening - shivering, aching joints. Sunday - achy, tired, beginning of swollen armpit region (gland?). Monday - swollen armpit region. Tuesday - attempted to follow up with patient, but unable to reach him.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysarthria, Seizure, Speech disorder
Clinical narrative: AE: Seizure upon admission to hospital, was sent to ER because of slurred speech and inappropriate responses to questions, had seizure after arriving at hospital, TX: KEPPRA at hospital, 1500mg/day, ATIVAN IV. In hosp for 12/24 to 12/28th. Sent home with KEPPRA & Buspirone.
Age: 2.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Aggression, Obsessive-compulsive disorder, Screaming
Clinical narrative: My 3 years old daughter has extreme O.C.D. now. Her tantrums are unmanageable. She throws herself to the floor uncontrollably which she can harm herself seriously. My daughter is unable to control herself, she has to slam every door in the house 3 times. If she hears someone open the a door in the home, she will run towards the door screaming to slam it. If she can't close it she will hit you, flop to the floor until she slam the door 3 times. (The same in school and outside). She has to enter the room, the home and classroom last, also.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLUA3
Symptoms: Condition aggravated, Decreased appetite, Ear infection, Influenza like illness, Irritability
Clinical narrative: Three days of fever 102, loss of appetite, fussiness, ear infection, cold/flu like symptoms.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLUA3
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: Three days of fever 102, loss of appetite, fussiness, ear infection, cold/flu like symptoms.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: The shot was given close to the shoulder joint and may have been injected into the joint. The patient complained of arm pain and the inability to raise her arm. The patient brought this to our attention on 2/26/19. Patient has not received any treatment for the pain, but has said it is getting a little better each day.
Age: 1.42
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blood test, Injection site nodule, Injection site reaction, Injection site warmth, Pyrexia
Clinical narrative: High fever and rash appeared 4.5 days after vaccination, fever is still consistent with rash 3 weeks later. Varicella injection site is just now having a reaction on 2/25/2019 that is continuing to grow accompanied with a knot and warm to touch sensation.
Age: 1.42
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: High fever and rash appeared 4.5 days after vaccination, fever is still consistent with rash 3 weeks later. Varicella injection site is just now having a reaction on 2/25/2019 that is continuing to grow accompanied with a knot and warm to touch sensation.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, Wrong product administered
Clinical narrative: Pt was given an expired MMRV vaccine at visit on 01/14/2019, as well as varicella vaccine. This visit, she was inadvertantly vaccinated with MMRV instead of plain MMR. We do not have any plain MMR VFC vaccines in stock and the MA that administered the dose thought the vaccine was the same as our private stock, which is plain MMR. The patient has now received 2 doses of Varicella, one expired MMRV, and one repeat dose of MMRV to cover the expired dose, resulting in over-vaccinating for varicella.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Leg became swollen, warm. Area approx. 20 mm x 30 mm today and mild erythema and edema. Patient went to the Pediatric Urgent Care on 02/23/19. He was given prescriptions for Cephalexin, Prednisone and Baclofen .
Age: 1.33
Sex: F
Vaccine: DTAP, HEP, HEPA, HIBV
Symptoms: Injection site bruising, Injection site mass, Injection site pain
Clinical narrative: Small lumps right thigh right after 2 injections given. 10 days later mother reports one lump about the size of a quarter. Tender to touch. Bruising also noted. No other symptoms.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Mom didn't notice any reaction first day as pt was wearing a long sleeve and went to bed because she wasn't feeling well due to food she ate before appt. Next morning around 9 AM mom went to shower pt and she noticed 9 cm x 4 cm red, raised, warm welt on Rt arm. By night time welt was 12 x 4 cm per mom that was the worst it got, then the redness. Area was warm to the touch. Area of reaction diminished until leaving a 5 cm x 4 cm bruise on right arm.
Age: 34.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Patient returned to clinic today for PPD reading and complaint of an itchy red rash on face which started on 2/20/2019 after returning home from work. Patient reports using an over the counter oral anti-histamine or allergy pill (could not recall name, however she was certain that it was not BENADRYL). No relief offered according to patient. Assessment today shows pruritic erythematous rash (hives) on facial cheeks, around mouth and chin. Referred to Primary Care Provider or ER.
Age: 16.0
Sex: M
Vaccine: HPVX, MENB, MNQ, HPVX, MENB, MNQ
Symptoms: Blood pressure decreased, Syncope, Tachycardia
Clinical narrative: Initial information received on 23-Feb-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a 16 years old male patient who experienced a vasovagal syncope and fainted with symptoms of a blood pressure of 70/38 and tachycardia, while he received vaccines HPV VACCINE, TRUMENBA and MENACTRA. The patient's past medical history, medical treatment(s), and family history were reported as none. Patient received MENACTRA at the age of 11 in past. On 31-Aug-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6015AA via intramuscular route in the right deltoid. On 31-Aug-2018, the patient received a 0.5 ml dose of suspect TRUMENBA not produced by Sanofi Pasteur lot T52805 via intramuscular route in the left deltoid. On 31-Aug-2018, the patient received a dose of suspect HPV VACCINE not produced by Sanofi Pasteur lot R003557 via intramuscular route in the left deltoid. On 31-Aug-2018, the patient developed a serious a vasovagal syncope and fainted within a minute or two, following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, following the administration of TRUMENBA and following the administration of HPV VACCINE. This event was assessed as medically significant. On 31-Aug-2018, the patient had a blood pressure of 70/38 and had tachycardia following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, following the administration of TRUMENBA and following the administration of HPV VACCINE. Other relevant tests included: The patient's blood pressure was taken right after he fainted on 31-Aug-2018. It was 70/38. His O2 sat was normal. The caller provides the normal for a patient his age should be about 120/80. Final diagnosis was a vasovagal syncope and fainted. It was not reported if the patient received a corrective treatment. The patient outcome is reported as recovered from events on 31 Aug 2018. Sender's Comments: This case involves a male patient who presented with vasovagal syncope/fainted, after vaccination with MENACTRA. Patient also received TRUMENBA and HPV vaccine on the same day. Time to onset is unknown however the events are expected with the role of vaccine. There is a possibility of contribution of other vaccine as well. Moreover, patient's underlying condition, past vaccine history and history of similar episode, condition at the time of vaccination and lab tests ruling out alternate etiologies are required for complete assessment of the case. Based on reported information role of individual vaccine cannot be assessed.
Age: 16.0
Sex: M
Vaccine: HPVX, MENB, MNQ, HPVX, MENB, MNQ
Symptoms: Hypotension, Syncope, Tachycardia
Clinical narrative: Initial information received on 23-Feb-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a 16 years old male patient who experienced a vasovagal syncope and fainted with symptoms of a blood pressure of 70/38 and tachycardia, while he received vaccines HPV VACCINE, TRUMENBA and MENACTRA. The patient's past medical history, medical treatment(s), and family history were reported as none. Patient received MENACTRA at the age of 11 in past. On 31-Aug-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6015AA via intramuscular route in the right deltoid. On 31-Aug-2018, the patient received a 0.5 ml dose of suspect TRUMENBA not produced by Sanofi Pasteur lot T52805 via intramuscular route in the left deltoid. On 31-Aug-2018, the patient received a dose of suspect HPV VACCINE not produced by Sanofi Pasteur lot R003557 via intramuscular route in the left deltoid. On 31-Aug-2018, the patient developed a serious a vasovagal syncope and fainted within a minute or two, following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, following the administration of TRUMENBA and following the administration of HPV VACCINE. This event was assessed as medically significant. On 31-Aug-2018, the patient had a blood pressure of 70/38 and had tachycardia following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, following the administration of TRUMENBA and following the administration of HPV VACCINE. Other relevant tests included: The patient's blood pressure was taken right after he fainted on 31-Aug-2018. It was 70/38. His O2 sat was normal. The caller provides the normal for a patient his age should be about 120/80. Final diagnosis was a vasovagal syncope and fainted. It was not reported if the patient received a corrective treatment. The patient outcome is reported as recovered from events on 31 Aug 2018. Sender's Comments: This case involves a male patient who presented with vasovagal syncope/fainted, after vaccination with MENACTRA. Patient also received TRUMENBA and HPV vaccine on the same day. Time to onset is unknown however the events are expected with the role of vaccine. There is a possibility of contribution of other vaccine as well. Moreover, patient's underlying condition, past vaccine history and history of similar episode, condition at the time of vaccination and lab tests ruling out alternate etiologies are required for complete assessment of the case. Based on reported information role of individual vaccine cannot be assessed.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoeic attack, Blood pH decreased, Blood potassium increased, Calcium ionised, Chest X-ray abnormal
Clinical narrative: Patient received PEDVAXHIB vaccine on 2/17, and decompensated shortly after that. Patient is a twin and both twins had the same reaction to the vaccines received. After administration of vaccines on 2/17, patient begin having increased oxygen requirements. Per provider note on 2/19, "had increased events after immunizations requiring NIPPV". Patient had event of bradycardia/desaturation, patient became apneic, cyanotic, HR in 40s and O2 saturation less than 10%. Did not respond to stimulation. CPAP was initiated and patient placed on NIPPV.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Continuous positive airway pressure, Endotracheal intubation, Haematocrit decreased, Haemoglobin decreased, Mechanical ventilation
Clinical narrative: Patient received PEDVAXHIB vaccine on 2/17, and decompensated shortly after that. Patient is a twin and both twins had the same reaction to the vaccines received. After administration of vaccines on 2/17, patient begin having increased oxygen requirements. Per provider note on 2/19, "had increased events after immunizations requiring NIPPV". Patient had event of bradycardia/desaturation, patient became apneic, cyanotic, HR in 40s and O2 saturation less than 10%. Did not respond to stimulation. CPAP was initiated and patient placed on NIPPV.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Oxygen saturation decreased, PCO2 increased, PO2 decreased, Packed red blood cell transfusion, Pulmonary haemorrhage
Clinical narrative: Patient received PEDVAXHIB vaccine on 2/17, and decompensated shortly after that. Patient is a twin and both twins had the same reaction to the vaccines received. After administration of vaccines on 2/17, patient begin having increased oxygen requirements. Per provider note on 2/19, "had increased events after immunizations requiring NIPPV". Patient had event of bradycardia/desaturation, patient became apneic, cyanotic, HR in 40s and O2 saturation less than 10%. Did not respond to stimulation. CPAP was initiated and patient placed on NIPPV.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Transfusion
Clinical narrative: Patient received PEDVAXHIB vaccine on 2/17, and decompensated shortly after that. Patient is a twin and both twins had the same reaction to the vaccines received. After administration of vaccines on 2/17, patient begin having increased oxygen requirements. Per provider note on 2/19, "had increased events after immunizations requiring NIPPV". Patient had event of bradycardia/desaturation, patient became apneic, cyanotic, HR in 40s and O2 saturation less than 10%. Did not respond to stimulation. CPAP was initiated and patient placed on NIPPV.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Acute respiratory failure, Bradycardia, Continuous positive airway pressure, Cyanosis, Infantile apnoea
Clinical narrative: Patient received PEDVAXHIB vaccine on 2/17, and decompensated shortly after that. Patient is a twin and both twins had the same reaction to the vaccines received. After administration of vaccines on 2/17, patient begin having increased oxygen requirements. Per provider note on 2/19, "had increased events after immunizations requiring NIPPV". Patient had event of bradycardia/desaturation, patient became apneic, cyanotic, HR in 40s and O2 saturation less than 10%. Did not respond to stimulation. CPAP was initiated and patient placed on NIPPV.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Neonatal hypoxia, Unresponsive to stimuli
Clinical narrative: Patient received PEDVAXHIB vaccine on 2/17, and decompensated shortly after that. Patient is a twin and both twins had the same reaction to the vaccines received. After administration of vaccines on 2/17, patient begin having increased oxygen requirements. Per provider note on 2/19, "had increased events after immunizations requiring NIPPV". Patient had event of bradycardia/desaturation, patient became apneic, cyanotic, HR in 40s and O2 saturation less than 10%. Did not respond to stimulation. CPAP was initiated and patient placed on NIPPV.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoeic attack, Dyspnoea, Heart rate decreased, Mechanical ventilation, Oxygen saturation decreased
Clinical narrative: Patient received PEDVAXHIB vaccine on 2/17, and decompensated shortly after that. Patient is a twin and both twins had the same reaction to the vaccines received. After administration of vaccines on 2/17, patient begin having increased oxygen requirements. Per provider note on 2/19, "had increased events after immunizations requiring NIPPV". Patient had event of bradycardia/desaturation, patient became apneic, cyanotic, HR in 40s and O2 saturation less than 10%. Did not respond to stimulation. CPAP was initiated and patient placed on NIPPV.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Pallor, Sleep apnoea syndrome
Clinical narrative: Patient received PEDVAXHIB vaccine on 2/17, and decompensated shortly after that. Patient is a twin and both twins had the same reaction to the vaccines received. After administration of vaccines on 2/17, patient begin having increased oxygen requirements. Per provider note on 2/19, "had increased events after immunizations requiring NIPPV". Patient had event of bradycardia/desaturation, patient became apneic, cyanotic, HR in 40s and O2 saturation less than 10%. Did not respond to stimulation. CPAP was initiated and patient placed on NIPPV.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Pruritus, Rash, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included shingles. On 6th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 6th February 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 12th February 2019, the patient experienced tingling, swelling, welts and pruritus. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the tingling, swelling, welts and pruritus were unknown. It was unknown if the reporter considered the injection site pain, tingling, swelling, welts and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX on left arm. The patient experienced injection site soreness for several days. More days passed and the patient left on a trip on 12th February 2019 and that evening she was lying on a pillow case in bed and her neck started to tingle. The patient touched her neck and she realized she had some bumps on her neck, upper arms and she had spots or welts on her back that were rectangular. The patient reported that her welts had tremendous itching. The patient started BENADRYL after a couple of days and all her symptoms are much improved now. The reporter consented to follow up.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Paraesthesia, Pruritus, Rash, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included shingles. On 6th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 6th February 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 12th February 2019, the patient experienced tingling, swelling, welts and pruritus. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the tingling, swelling, welts and pruritus were unknown. It was unknown if the reporter considered the injection site pain, tingling, swelling, welts and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX on left arm. The patient experienced injection site soreness for several days. More days passed and the patient left on a trip on 12th February 2019 and that evening she was lying on a pillow case in bed and her neck started to tingle. The patient touched her neck and she realized she had some bumps on her neck, upper arms and she had spots or welts on her back that were rectangular. The patient reported that her welts had tremendous itching. The patient started BENADRYL after a couple of days and all her symptoms are much improved now. The reporter consented to follow up.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included shingles. On 6th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 6th February 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 12th February 2019, the patient experienced tingling, swelling, welts and pruritus. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the tingling, swelling, welts and pruritus were unknown. It was unknown if the reporter considered the injection site pain, tingling, swelling, welts and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX on left arm. The patient experienced injection site soreness for several days. More days passed and the patient left on a trip on 12th February 2019 and that evening she was lying on a pillow case in bed and her neck started to tingle. The patient touched her neck and she realized she had some bumps on her neck, upper arms and she had spots or welts on her back that were rectangular. The patient reported that her welts had tremendous itching. The patient started BENADRYL after a couple of days and all her symptoms are much improved now. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Pt called today stating that she had severe chills that kept her up at night and also a severe headache.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Injection site pain, Injection site swelling
Clinical narrative: 1. Left arm was puffy and very sore around the injection site (within ~2 inches of the injection site). 2. During the night, I was very cold and shivering for several hours.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Headache, chills, sore muscles.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 11 years old male patient. The patients' pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 13-NOV-2018, the patient received improperly stored dose of GARDASIL 9 lot# R002345, expiration date 16-NOV-2020 (exact dose and route of administration were not reported) for prophylaxis. No adverse effects reported. The vaccine was exposed to a temperature of -1.1 degree Celsius (below 0 degree Celsius) for 8 hours 10 minutes. No previous temperature excursion was reported. The call was because of a digital data logger. This is a non-valid report due to lack of patient identifiers. This case was related to MARSS# 1902USA011294 and 1902USA011295 (Same reporter link).
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 25-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 05-JUL-2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (dose, lot # and expiration date were not reported) for prophylaxis. The patient received her second dose of GARDASIL 9 intramuscularly (dose, lot # and expiration date were not reported) for prophylaxis on an unknown date in November 2018. On 04-FEB-2019, the patient received the third dose of GARDASIL 9 intramuscularly, lot #: 1581027, expiration date: 03-JUN-2021 (dose was not provided) for prophylaxis. There was no adverse event reported.
Sex: M
Vaccine: HPV9
Symptoms: Product appearance confusion
Clinical narrative: This spontaneous report was received from a male consumer of an unknown age reporting on him/her self via a company representative. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies were not provided. On 04-FEB-2019, the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, strength, dose, route and anatomical location were not provided) for prophylaxis. The patient reported that he was concerned that the liquid that was in the syringe was "clear", it was cloudy and white. The patient reported that "the unidentified pharmacist at the pharmacy shook the GARDASIL 9 a couple of times and the administered GARDASIL 9 was clear".
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Feeling abnormal, Oropharyngeal pain, Panic attack
Clinical narrative: This spontaneous report has been received from a physician, referring to a 14 years old female patient. Information about the patient's pertinent medical history, previous drug reactions, allergies and concomitant medication was unknown by the physician. On an unspecified day in February 2018 (reported as "a year ago") the patient was vaccinated with one dosage form of GARDASIL 9 injection, as prevention of human papillomavirus (HPV) (dose number and frequency in vaccine series was not reported; route and anatomical location of vaccination, lot number and expiration date were unknown by the physician). The physician reported that, since an unspecified date after vaccination with GARDASIL 9 the patient began to experience panic attacks. The physician described the panic attacks as happening at random times during the unspecified days and stated that when they happened, the patient did not know where she was and seemed confused, like if she did not know what she should do. In addition, the physician mentioned that the panic attacks scared the patient, as she started to breathe fast and sometimes got dizzy. The patient was reported to be extremely tired after the panic attacks happened. According to the physician, the patient had had 2 to 3 episodes over the 2018 summer (reported as "past summer") which lasted from 30 minutes to several hours. On 04-JAN-2019 (reported as "6 weeks ago") the patient sought for medical attention and visited a neurologist who performed her a 24 hour electroencephalogram (EEG) and an unspecified bloodwork as diagnostic studies; however, both resulted normal. The patient was prescribed topiramate 25 milligrams (mg), once daily in the evening, as treatment. On an unspecified date, the patient also visited an endocrinologist, who informed her that her panic attacks were caused by GARDASIL 9. The physician reported that, since November 2018 (reported as "in the past 3 months") the patient had not had any panic attacks and, by reporting time, she had not needed to take topiramate anymore. However; on an unspecified date in February 2019 (reported as "over the past week") the panic attacks had gotten worse and more frequent as the physician described that, on 14-FEB-2019 (reported as "yesterday") the patient was sitting in class and she felt like someone "had pressed a slow-motion button" and she felt very weird. It was reported that she walked to her next class, where she felt like she and other people were moving slow and she felt like she should not be there. Finally, the physician also reported that since an unspecified date after administration of GARDASIL 9 the patient had constantly had a sore throat. By reporting time, the patient had not recovered from panic reaction, fatigue and oropharyngeal pain. The physician causality assessment between the occurred events and vaccination with GARDASIL 9 was not reported.